Month: February 2022

SOP for Inventory Control of Materials and Components

Posted on By ABHA

SOP for Inventory Control of Materials and Components

Objective

  • To lay down a procedure of Inventory Control of all the materials and components for the handling of receipt, storage, and disposal of all the Raw Materials, Packing Materials, and Finished Goods, Obsolete or Outdated / Returned / Rejected materials.

Scope

  • This Standard Operating Procedure is applicable in Stores for the personnel dealing with Raw Materials, Packing Materials, and Finished Goods for Inventory Control of Materials and Components.

Inventory Control

Responsibility

  • Concerned Store personnel shall be responsible to follow the procedure mentioned in this SOP.
  • The concerned Store in charge shall be responsible for the implementation of the procedure mentioned in this SOP.

Accountability

Concerned Store in-charge & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

  • SOP:            Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
  • QA:            Quality Assurance
  • Ltd.:            Limited
  • GMP:            Good Manufacturing Practices

Procedure

Procedure for Inventory Control of Materials and Components

  • The In-charge of Raw Material Store, Packing Material Store, and Finished Goods Store shall maintain proper records in respect to the Inventory Control of Materials and Components.

Inventory Control regarding Raw Materials:-The following records shall be maintained by the Incharge of the Raw Material Store in which necessary inventories shall be regularly made:

1. Raw Material Receipt Note:- The inventories of the following particulars shall be made in this record:

    1. R.M receipt No. / GRN No. and Date
    2. Invoice No. and Date
  • Name and address of the supplier
  1. Name and address of the transporter
  2. Gate entry date and vehicle No.
  3. Name of material and its Batch No,
  4. No. of containers and quantity in each
  5. Rate, Amount, and Tax
  6. Quantity in Invoice, Quantity received, and Shortage, if any.

2. Daily Receipt Record:- In this record, the following inventories shall be made:

  1. GRN No. and Date
  2. Vendor’s Name
  3. Name of an item and its Code No.
  4. Quantity Received

3. GRN intimation sent to QC Department:- Inventories of the following particulars shall be made in this intimation record:

  1. Item Name
  2. Supplier Name
  3. GRN No. and Date
  4. Invoice No. and Date
  5. Batch No. and Batch Quantity
  6. No. of containers
  7. Manufacturer
  8. Intimation date

NOTE: –  

  • The material on the receipt shall be stored in the quarantine area. The Quality Control after taking the sample of material shall label the containers with the status label of “Quarantine-Sampled” which shall be of Yellow color.
  • The Quality Control after testing shall put the status label of “Released” of green colour in case of results complies or “Rejected” of Red colour, in case of not results complies.
  • The Passed / released material shall be stored at proper storing condition in the approved Raw Material Store and the Rejected material shall be shifted to the Rejected Goods Store.
  1. Raw Material Issue Note :- The Incharge of Raw Material Store shall make the inventories of the following particulars in this record for the supply of materials to the Production Department on the basis of Requisition Slip produced by the Production Department:
  2. Name of the Department to whom issued
  3. Document / Issue No. and Date
  4. Requisition No. and Date
  5. Product to be manufactured, its Batch No., Batch Size, Mfg. date, Exp. Date and Unit Qty.
  6. Name of the material issued, Required Qty., Qty. issued, GRN No., Q.C. No. and Issued Qty.
  1. Stock Sheet :- In this record, inventories of the below noted particulars shall be made:
  2. Date
  3. Name of Raw Material and its Code No.
  • Opening balance, Batch No. and Mfg. Date
  1. Supplier’s Name and Address
  2. Manufacturer’s Name and Address
  3. Invoice No. and Dateof containers received
  4. Shortage, if any issued
  5. Name of product for which issued, its Batch No. and Batch Size
  • Closing balance
    • Inventory Control regarding Packing Materials :- The following records shall be maintained by the in-charge of the Packing Material Store in which necessary inventories shall be regularly made:
    • Packing Material receipt Note: – The inventories of following particulars shall be made in this record.
  1. GRN No. and Date
  2. Name of supplier
  • Invoice No. and Date in Invoice, Qty. received and difference
  1. Item Name, Qty. and No. of boxes
  2. Rate, Amount, Taxes and Freight charges
  3. Gate entry, Date and vehicle No.
  4. Transporter’s Name

GRN intimation sent to QC Department:- In this record, inventories of following particulars shall be made:

  1. Item Name
  2. Supplier Name
  3. GRN No. and Date
  4. Invoice No. and Date
  5. Batch No. and Batch Quantity of containers
  6. Manufacturer
  7. Intimation

  NOTE:-

  • The material on receipt shall be stored in the quarantine area. The Quality Control after taking the sample of material shall label the containers with status label of “Quarantine-Sampled” which shall be of yellow Colour.
  • The Quality Control after testing shall put status label of “Released” of green colour in case of results complies or “Rejected” of Red colour, in case of results not complies.
  • The Passed / released material shall be stored at proper storing condition in the approved Packing Material Store and the Rejected material shall be shifted to the “Rejected Goods Stor

Packing material Issue Note :- The In-charge of Packing Material Store shall make the inventories of the following particulars in this record for the supply of material to the Production Department on the basis of Requisition Slip produced by the Production Department:

  1. Name of the Department to whom issued
  2. Document / Issue No. and Date
  3. Requisition No. and Date
  4. Product to be manufactured, its Batch No, Batch Size, Mfg. date, Exp. Date and Unit Qty.
  5. Name of the material issued, Required Qty., Qty. issued, GRN No., Q.C. No. and Issued Qty.

Packing Material Returned from Production :- In this record, the inventories of following particulars shall be made:

  1. Product Name and its Batch No.
  2. Return Note No. and Date
  3. Production section, Batch Size, Mfg. Month and Exp. Month
  4. Unit Size and Pack Size

Stock Sheet :- In this record the inventories of following particulars shall be made:

    1. Issue No. and Date
    2. Name of item and its A.R. No.
    3. Department to whom issued
    4. Name of product for which issued, its Batch No. and Batch size
    5. Opening balance, Qty. issued and closing balance

Inventory Control regarding Finished Goods :- The following records shall be maintained by the in charge of the Finished Goods Store in which necessary inventories shall be regularly made:

  1. Stock and Sale statement :- In this record the inventories of following particulars shall be made:
  2. No. and Date
  3. Name of product with unit size
  4. Opening stock received from production
  5. Total Qty.
  6. sold
  7. Closing balance

NOTE:-

  •  The inventories in this record shall be made by the finished goods incharge after the receipt of “Daily Production Slip” received from production department and “Release Order” from Quality Assurance department.

Sale Inventory Stock Statement :- In this record the inventories of following particulars shall be made:

  1. No and Date
  2. Product Code, Product Name with Unit size
  • Opening Stock
  1. Opening Stock value
  2. received from Production
  3. sold
  • Closing stock
  • Closing stock value

Sale Invoice :- In this record the inventories of following particulars shall be made:

  1. No. and Date
  2. Name of product, its Unit size, Batch No. and Exp. Date
  • of boxes and Qty. in each box
  1. Total qty.
  2. MRP per unit
  3. Rate per unit
  • Total value
  • Excise duty, Cess on E.D. and Sales tax.
    • The In-charge of stores for Raw Material, Packing Material and Finished Goods shall strictly follow the system of “First In- First Out” to ensure that the oldest approved product or material is used first.
    • The Rejected, Out-dated, Returned / Recalled Finished Goods shall be stored separately from rest of the stocks at the space allocated for this purpose. After clearance from the Managing Director / Executive Director the same shall be destroyed as per SOP titled as “Disposal & Destruction of material” Proper destruction record shall be maintained.
    • The rejected, obsolete or Out-dated raw materials and packing materials shall be stored in a separate room meant for this purpose only and labeled as “Rejected / Out-dated materials” and proper records shall be maintained in this regard separately for Raw Materials and Packing Materials by their store incharges under intimation to Quality Assurance Department.
    • The rejected, returned, recalled, obsolete or outdated raw materials, packing materials and finished goods shall be destroyed as per the procedure laid in the SOP titled “Disposal & Destruction of material”.

Forms and Records (Annexures)

    • Not applicable

Distribution

    • Master copy               –                   Quality Assurance
    • Controlled copies             –                   Quality Assurance, Store, Production

History

For more Pharma posts and updates click Here

 

SOPs

Stock Rotation of Raw Materials, Packing Materials and Finished Goods on the “First-in, First-out” basis

Posted on By ABHA

Stock Rotation of Raw Materials, Packing Materials and Finished Goods on the “First-in, First-out” basis

Objective

  • To lay down a procedure to ensure proper stock rotation of Raw materials, Packing Materials and Finished Goods so that the stock rotation of the materials may be on the “First-in,First-out” basis.

Scope

  • This Standard Operating Procedure is applicable in Store for Stock Rotation of Raw Materials, Packing Materials and Finished Goods on the “First-in, First-out” basis at formulation plant

Responsibility

  • Store personnel shall be responsible to follow the procedure mentioned in this SOP.
  • Store in charge shall be responsible for the implementation of the procedure mentioned in this SOP.

Accountability

  • Store Incharge & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

  • SOP:            Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
  • QA:            Quality Assurance
  • FIFO:            First In First Out

First-in,First-out

Procedure

  • The persons holding charges of the stores of Raw Materials, Packing Materials and Finished Goods shall maintain their stores adopting a system to avoid the materials brought earlier may not remain in the store without disposal for a long time by dispatching the later ones.
  • The persons holding charges of stores shall adopt the procedure of the proper stock rotation of the materials stored by them on the basis of “First-in, First-out” (FIFO).
  • The materials shall be stored in such a way to enable quick identification and stock movement.
  • The stocks should be racked and stored in a manner that earlier stocks are more easily accessible than the later ones.
  • The stock received should be with proper documents detailing the name of the material, the batch number, quantity received, and date of expiry, if any.
  • The stock control system must be such that only passed lots (released) are issued.
  • The materials should be stored on shelves at convenient heights and with proper labels which clearly identify the materials and with status labels of “Released” on each packing.
  • List of materials giving details such as their names, batch numbers, date of manufacture and date of Expiry, if any, and quantities in stock, should be prepared.
  • The stock rotation shall be such that the materials are disposed of on the “First-in, First-out” basis, i.e. in sequence of their receipt to avoid disposal of any material received later than the one received earlier.

Forms and Records (Annexures)

  • Not Applicable

Distribution

  • Master copy         –   Quality Assurance
  • Controlled copies        –  Quality Assurance, Store

History

For more Pharma posts and updates click Here

 

 

SOPs

Dispensing of raw materials and transfer of dispensed materials from RM store to Production

Posted on By ABHA

Dispensing of raw materials and transfer of dispensed materials from RM store to Production

Objective

  • To lay down a procedure for dispensing of raw materials and transfer of dispensed materials from RM stores to various sections of the Production Department.

Scope

  • This Standard Operating Procedure is applicable at Raw Material Store for dispensing of Raw Materials and their transfer to the various sections of the Production Department at formulation plant

Responsibility

  • Raw material Store and Production personnel shall be responsible to follow the procedure mentioned in this SOP.
  • Raw material Store and Production in charge shall be responsible for the implementation of the procedure mentioned in this SOP.

Accountability

  • Raw material Store in-charge & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

  • SOP:            Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
  • QA:Quality Assurance
  • Ltd.: Limited
  • BMR: Batch Manufacturing Record
  • RM: Raw material
  • RLAF: Reverse Laminar Air Flow
  • AR. No.:Analytical Report Number
  • API: Active Pharmaceutical Ingredient
  • FIFO: First In First Out
  • FEFO: First Expiry First Out
  • ERP: Enterprises Resource Planning
  • Mfg. :  Manufacturing
  • Exp.: Expiry
  • SS: Stainless Steel
  • IPA:Isopropyl Alcohol

dispensing of raw materials

Procedure for Dispensing of raw materials

Procedure

    • Pre-start up activity for dispensing & Issuance of Raw material:
      • On the receipt of the requisition slip from the production department for the manufacture of a product, the store personnel shall ensure that the requisition slip bears the signature of all the concerned persons and verify the availability of “Approved Stocks” required for the concerned batch.
      • After that store personnel shall generate dispensing sheet and issue note with auto generated A.R No. along with Batch No. of the material through ERP. The store personnel shall dispense the materials on the basis of “First Expiry First Out” (FEFO) followed by “First In First Out” (FIFO) system as per dispensing sheet and issue note.
      • Before starting the dispensing, Raw Material Store & production personnel or their  trained personnel shall ensure the following:
        • Area and equipments are cleaned.
        • Scoops, spatulas and other utensils shall be neat and clean.
        • Personnel engaged in the dispensing activity shall bear protective garments including hand gloves, masks and where necessary safety glasses and gas masks.
        • Differential Pressure, Temperature and Relative Humidity of dispensing area are within the specified limit.
        • Documents of previous products are removed from area.
        • Cleaned pallets are kept for staging the materials.
        • All the log books of the respective areas are updated.
        • Approved materials are to be dispensed.
        • The RLAF is switched “ON” 15 -20 minutes before the dispensing activity starts.
        • One item of a batch shall be dispensed at a time for one batch.
      • The issue note shall be signed by the concerned persons before compounding the raw material.

Dispensing of Active & Inactive Raw Materials

    • Production personnel shall calculate the exact quantity of API and excipient with which the API is to be adjusted according to standard batch size (if applicable), as mentioned in BMR and same shall be verified by QA personnel.
    • Take line clearance from QA personnel before starting the dispensing activity and attach it to BMR.
    • After Line Clearance, Store, production & QA personnel shall supervise the weighing/measuring of the raw materials.
    • Dispensing shall be done in controlled conditions, under RLAF.
    • Store personnel shall bring all the required raw materials (both active and inactive) from the approved RM Store to the dispensing booth through the pass boxes.
    • The dispensing of all the raw materials shall be carried out by the store personnel in the presence of the RM Store in-charge, production and QA personnel.
    • All inactive ingredients shall be dispensed before active ingredients, except colors and flavors which shall be dispensed at the last.
    • If the product has more than one active ingredient, then the lower potency API shall be dispensed first followed by the API with a higher potency.
    • Weigh sequentially, correct quantities of raw materials in a double lined poly bag. Twist the inner poly bag, fold it in U-shape and seal it with a cable tie.
    • Put “Dispensed” label in between two poly bag & twist the outer poly bag, fold it in U-shape and seal it with a cable tie.
    • The “Dispensed” label which is also known as “Material Issue Slip” shall be filled with details like Mfg. Date & Exp. Date in case of API only and not required in the excipients.
    • In case of light sensitive material, switch off tube lights of dispensing booth before dispensing. Dispense the material in black polythene bag (as inner bag), twist and seal it with a cable tie.
    • Put this black inner poly bag in another new, transparent poly bag along with the “Dispensed” label.
    • Dispensing of colors and flavors shall be done only after switching “OFF” the RLAF.
    • The required quantity of colors and/ or flavors shall be weighed and put in a poly bag or butter paper (whatever is appropriate as per quantity to be dispensed) and this poly bag/ butter paper shall be put in a new poly bag along with the “Dispensed” label.
  • During dispensing the persons supervising the dispensing operation shall check the following particulars regarding each dispensed materials:
    • Physical status of the container of the raw material.
    • Name of the raw material, its batch No. and date of expiry
    • R. No.
    • Pharmacopoeial specification
  • Entries regarding the dispensed raw materials shall be made in the dispensing sheet by the production personnel and all the entries shall be signed by the store, production and QA personnel’s.
  • The dispensed raw materials shall be taken out of the dispensing area through the pass box and shall be taken to the production section through the material movement corridor.
  • From the material movement corridor the dispensed materials shall be taken to the batch preparation room through a pass box.
  • After dispensing, the containers from which a raw material is dispensed shall be closed effectively, sealed and labeled as “LOOSE”.
  • All the liquid raw materials shall be dispensed in clean and dry SS containers.
  • After dispensing the balanced raw materials shall be taken back to approved raw material store and the dispensing booth and equipments used for dispensing shall be thoroughly clean and necessary entry shall be made in the log book maintained for this purpose.
  • Dispensing of the sterile raw materials shall be made under laminar flow in the Aseptic Area. Before taking the container into the Aseptic Area it shall be disinfected with IPA (70%) from outside (if required).
  • The dispensed raw materials which are to be taken to the Aseptic Area shall be sent through a pass box to the batch manufacturing room and before placing the material in the pass box containers shall be disinfected with IPA from outside.
  • In case of dispensing of hard gelatin capsules, the supply shall be made by weight in excess of the requirement for the processing of the batch of a product and the excess unused capsules shall be returned by the production section to the RM Store by weight.
  • Record the dispensing activity in Sequential Equipment Logbook.
  • After completion of dispensing activity, the area shall be cleaned thoroughly and cleaning details shall be recorded in Sequential Equipment Logbook.

 Issuance of additional Raw materials:

    • The additional raw material shall be issued to production department under following circumstances:
      • On Line rejection.
      • Re-processing.
      • Spillage and Wastage of materials during transit or production activity.
    • Production department shall raise a requisition in form of “Additional Material Requisition Note” in duplicate for the additional requirement of raw material which shall be duly authorized by Head-QA after investigating the reason for additional requirement for raw materials.
    • After receiving the “Additional Material Requisition Note” from production, the material shall be dispensed as per above step.
    • One copy of “Additional Material Requisition Note” shall be attached in the additional material issuance file for warehouse record and a second copy shall be given to respective department head to attach it in the BMR (if applicable).

Forms and Records (Annexures)

  • Not applicable

Distribution

  • Master copy               –                   Quality Assurance
  • Controlled copies             –                   Quality Assurance, Raw Material Store, Production

History

For more Pharma posts and updates click Here

 

SOPs

Dispensing of raw materials and transfer of dispensed materials from RM store to Production

Posted on By ABHA

Objective

  • To lay down a procedure for dispensing of raw materials and transfer of dispensed materials from RM stores to various sections of the Production Department.

Scope

  • This Standard Operating Procedure is applicable at Raw Material Store for dispensing of Raw Materials and their transfer to the various sections of the Production Department at formulation plant.

Responsibility

  • Raw material Store and Production personnel shall be responsible to follow the procedure mentioned in this SOP.
  • Raw material Store and Production in-charge shall be responsible for implementation of the procedure mentioned in this SOP.

Accountability

  • Raw material Store in-charge & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

  • SOP: Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
  • QA:            Quality Assurance
  • Ltd.:            Limited
  • BMR:            Batch Manufacturing Record
  • RM:            Raw material
  • RLAF:            Reverse Laminar Air Flow
  • R. No.  :            Analytical Report Number
  • API     :            Active Pharmaceutical Ingredient
  • FIFO:            First In First Out
  • FEFO:            First Expiry First Out
  • ERP:             Enterprises Resource Planning
  • Mfg.                            :            Manufacturing
  • Exp.                             :            Expiry
  • SS:            Stainless Steel
  • IPA:            Isopropyl Alcohol

Procedure

Pre-start up activity for dispensing & Issuance of Raw material:

  • On the receipt of the requisition slip from the production department for the manufacture of a product, the store personnel shall ensure that the requisition slip bears the signature of all the concerned persons and verify the availability of “Approved Stocks” required for the concerned batch.
  • After that store personnel shall generate dispensing sheet and issue a note with auto-generated A.R No. along with Batch No. of the material through ERP. The store personnel shall dispense the materials on the basis of “First Expiry First Out” (FEFO) followed by “First In First Out” (FIFO) system as per dispensing sheet and issue note.
  • Before starting the dispensing, Raw Material Store & production personnel or their  trained personnel shall ensure the following:
  • Area and equipment are cleaned.
  • Scoops, spatulas, and other utensils shall be neat and clean.
  • Personnel engaged in the dispensing activity shall bear protective garments including hand gloves, masks, and where necessary safety glasses and gas masks.
  • Differential Pressure, Temperature, and Relative Humidity of dispensing area are within the specified limit.
  • Documents of previous products are removed from the area.
  • Cleaned pallets are kept for staging the materials.
  • All the logbooks of the respective areas are updated.
  • Approved materials are to be dispensed.
  • The RLAF is switched “ON” 15 -20 minutes before the dispensing activity starts.
  • One item of a batch shall be dispensed at a time for one batch.
  • The issue note shall be signed by the concerned persons before compounding the raw material.

Dispensing of Active & Inactive Raw Materials

  • Production personnel shall calculate the exact quantity of API and excipient with which the API is to be adjusted according to standard batch size (if applicable), as mentioned in BMR and the same shall be verified by QA personnel.
  • Take line clearance from QA personnel before starting the dispensing activity and attach it to BMR.
  • After Line Clearance, Store, production & QA personnel shall supervise the weighing/measuring of the raw materials.
  • Dispensing shall be done in controlled conditions, under RLAF.
  • Store personnel shall bring all the required raw materials (both active and inactive) from the approved RM Store to the dispensing booth through the pass boxes.
  • The dispensing of all the raw materials shall be carried out by the store personnel in the presence of the RM Store in charge, production, and QA personnel.
  • All inactive ingredients shall be dispensed before active ingredients, except colors and flavors which shall be dispensed at the last.
  • If the product has more than one active ingredient, then the lower potency API shall be dispensed first followed by the API with a higher potency.
  • Weigh sequentially, correct quantities of raw materials in a double-lined poly bag. Twist the inner polybag, fold it in U-shape and seal it with a cable tie.
  • Put the “Dispensed” label in between two poly bag & twist the outer polybag, fold it in U-shape and seal it with a cable tie.
  • The “Dispensed” label which is also known as “Material Issue Slip” shall be filled with details like Mfg. Date & Exp. Date in case of API only and not required in the excipients.
  • In case of light-sensitive material, switch off tube lights of dispensing booth before dispensing. Dispense the material in a black polythene bag (as the inner bag), twist, and seal it with a cable tie.
  • Put this black inner poly bag in another new, transparent polybag along with the “Dispensed” label.
  • Dispensing of colors and flavors shall be done only after switching “OFF” the RLAF.
  • The required quantity of colors and/ or flavors shall be weighed and put in a poly bag or butter paper (whatever is appropriate as per quantity to be dispensed) and this polybag/butter paper shall be put in a new polybag along with the “Dispensed” label.
  • During dispensing the persons supervising the dispensing operation shall check the following particulars regarding each dispensed material:
  • Physical status of the container of the raw material.
  • Name of the raw material, its batch No. and date of expiry
  • R. No.
  • Pharmacopoeial specification
  • Entries regarding the dispensed raw materials shall be made in the dispensing sheet by the production personnel and all the entries shall be signed by the store, production, and QA personnel.
  • The dispensed raw materials shall be taken out of the dispensing area through the pass box and shall be taken to the production section through the material movement corridor.
  • From the material movement corridor, the dispensed materials shall be taken to the batch preparation room through a pass box.
  • After dispensing, the containers from which raw material is dispensed shall be closed effectively, sealed, and labeled as “LOOSE”.
  • All the liquid raw materials shall be dispensed in clean and dry SS containers.
  • After dispensing the balanced raw materials shall be taken back to the approved raw material store and the dispensing booth and equipment used for dispensing shall be thoroughly clean and necessary entry shall be made in the logbook maintained for this purpose.
  • Dispensing of the sterile raw materials shall be made under laminar flow in the Aseptic Area. Before taking the container into the Aseptic Area it shall be disinfected with IPA (70%) from outside (if required).
  • The dispensed raw materials which are to be taken to the Aseptic Area shall be sent through a pass box to the batch manufacturing room and before placing the material in the pass box containers shall be disinfected with IPA from outside.
  • In case of dispensing of hard gelatin capsules, the supply shall be made by weight in excess of the requirement for the processing of the batch of a product and the excess unused capsules shall be returned by the production section to the RM Store by weight.
  • Record the dispensing activity in Sequential Equipment Logbook.
  • After completion of dispensing activity, the area shall be cleaned thoroughly, and cleaning details shall be recorded in Sequential Equipment Logbook.Raw materials

Issuance of additional Raw materials:

The additional raw material shall be issued to the production department under the following circumstances:

On-Line rejection.

  • Re-processing.
  • Spillage and Wastage of materials during transit or production activity.
  • The production department shall raise a requisition in form of “Additional Material Requisition Note” in duplicate for the additional requirement of raw material which shall be duly authorized by Head-QA after investigating the reason for the additional requirement for raw materials.
  • After receiving the “Additional Material Requisition Note” from production, the material shall be dispensed as per the above step.
  • One copy of “Additional Material Requisition Note” shall be attached in the additional material issuance file for warehouse record and a second copy shall be given to the respective department head to attach it in the BMR (if applicable).

Forms and Records (Annexures)

  • Not applicable

Distribution

  • Master copy               –                   Quality Assurance
  • Controlled copies             –                   Quality Assurance, Raw Material Store, Production

History

DateRevision Number                Reason for Revision
0          New SOP

 

SOPs, Uncategorized

In-House Laundry Procedure

Posted on By ABHA

Objective

  • To lay down a procedure for In-House laundry.

Scope

  • This SOP is applicable for laundering different types of Protective Garments of employees engaged in the manufacture of drugs according to the nature of their duties of all departments in the formulation plant of Pharmaceuticals industries.

Responsibility

  • Housekeeping personnel is responsible to follow the procedure mentioned in an SOP.
  • HR Department is responsible for the implementation of the procedure mentioned in this SOP.

Accountability

  • Head HR and QA shall be accountable for the compliance of this SOP.

Abbreviations and Definitions

  • SOP       Standard Operating Procedure
  • QA:       Quality Assurance
  • GMP:     Good Manufacturing Practices

Procedure

  • Different types of Protective Garments used in different manufacturing areas are –
  • Uniforms are worn by the employees working in the Primary areas of different sections such as – QA, laboratory, Raw Material Store, Parentrals, Oral liquid, Tablet, Capsule, External Preparations.
  • Uniforms are worn by the employees working in the secondary areas such as Parentrals, Oral liquid, Tablet, Capsule, External Preparations.
  • One personnel from the Housekeeping is deputed for cleaning of Protective Garments of Primary Area and Secondary Area of all departments separately at a scheduled time interval twice a week or whenever required.
  • Protective garments of employees working in aseptic areas cannot be dealt with other garments so these shall be cleaned separately in the washing room near the manufacturing area.
  • Other protective garments shall be cleaned in the laundry room which is situated outside the manufacturing area in the factory premises.
  • Protective garments of an aseptic section shall be cleaned each Wednesday and Saturday as per schedule.
  • Primary Area garments shall be cleaned each Monday and Thursday as per schedule.
  • Secondary Area garments shall be cleaned each Tuesday and Friday as per schedule.
  • Collect the uncleaned Primary Area garments or Secondary Area garments to the designated area for washing.
  • The washerman makes a count of the uncleaned garments of Primary Area or Secondary.
  • The count shall be counter-checked by the designated person from the Housekeeping department.
  • Note: Booty shall be cleaned separately as booty is more soiled and can cause difficulty in cleaning primary garments.
  • Laundry

Procedure for Washing of protective garments:

  • Transfer the protective garments to the washing area for washing.
  • Fill the washing machine with water.
  • Add a half-packet or required qty. of detergent in it.
  • Put the uncleaned garments in the washing machine.
  • Switch “on” the washing machine.
  • Set the Timer button on a minimum of ten minutes.
  • Let the machine run for ten minutes.
  • As soon as the ten minutes will complete the machine will stop automatically.
  • Fill the two buckets with water.
  • Remove the garments from the washing machine and keep them in the filled bucket.
  • Start the water tap and keep another bucket under the tap.
  • Rinse the cloth again and again to remove all the traces of detergent.
  • Now fill a bucket of water again and add the required quantity of Blue to it.
  • Rinse all the white color garments in the same bucket.
  • Put all the washed clothes in the drier.
  • Set the Timer button.
  • Let the drier run.
  • Remove the clean & dry garments from the drier when it stops.
  • After drying the same, Iron all the garments.
  • Pack one by one in the polybag.
  • Transfer the clean protective garments from the washing Area to the respective department’s change room.

Forms and Records (Annexures)

  • Cleaning Record of Protective Garments                      –                    Annexure – I

Distribution

  • Master copy           –       Documentation Cell (QA)
  • Controlled copies     –        Quality Assurance, Production, Quality Control, Store

History

DateRevision Number               Reason for Revision
I                Periodic revision

 

SOPs

Chlorination & sanitization of chlorine dosing tank

Posted on By ABHA

Objective

  • To lay down a procedure of Chlorination & sanitization of chlorine dosing tank.

Scope

  • This SOP is applicable for the chlorination process and sanitization of the chlorine dosing tank in the formulation plant.

Responsibility

  • Operator / Technician shall be responsible for chlorination and chemical sanitization of chlorine dosing tank.
  • Engineering personnel shall be responsible for checking the chlorination & sanitization.

Accountability

  • Department Head & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

  • QA:            Quality Assurance
  • SOP:            Standard Operating Procedure
  • QC:           Quality Control

Procedure

Chlorination:

  • Chlorination shall be done by 6.0% w/v sodium hypochlorite solution.
  • Take 45 liters of fresh raw water in a dosing tank.
  • Prepare the sodium hypochlorite solution having a concentration of 6.0 % w/v.
  • Add 5 liter of prepared sodium hypochlorite solution into the dosing tank and stir with S.S. ladle to form a uniform solution.
  • Maintain the free chlorine level is about 2 ppm by adjusting the dosing rate.
  • After chlorination, the sampling valve of the sampling point shall open and water shall be drained for at least five minutes.
  • Water sample shall be taken by the operator from sampling point no. and this sample shall be sent to QC to check the free chlorine level in the water.
  • Sodium hypochlorite solution preparation & consumption record shall be maintained as per annexure-I
  • Frequency: Daily

Sanitization

  • Drain the content of the dosing tank.
  • Clean with raw water.
  • Take 50 liters of potable water in the dosing tank.
  • Add 50 ml of sodium hypochlorite solution (6% w/v concentration- Approx.) in the dosing tank & stir with the help of S.S ladle.
  • Remove the dosing pump tubing from the dosing line & put it into the dosing tank and run the dosing pump for 30 to 60 minutes.
  • Keep the tank filled with sodium hypochlorite solution for 4 hours.
  • Clean the tank with potable water having 1-2 ppm of available chlorine.
  • After completion of cleaning, the tank is ready to use.
  • Sanitization of chlorine dosing tank shall be planned in a holiday to avoid the shortage of water.
  • Sanitization record shall be maintained
  • Frequency: Monthly

Forms and Records (Annexures)

  • Sodium Hypochlorite Solution Preparation & consumption Record –        Annexure-I
  • Sanitization of Chlorine Dosing Tank                                        –        Annexure-II

Distribution

  • Master copy        –             Quality Assurance
  • Controlled copies –             Quality Assurance & Engineering

History

DateRevision Number                 Reason for Revision
0   New SOP

Annexure-I

Sodium Hypochlorite Solution Preparation & Consumption Record

DateQty. receivedReceived  byQty. usedBalance Qty.Sodium Hypochlorite Solution Preparation (NaOCl)Checked by
Qty. of NaOClQty. of waterTotal Quantity PreparedSolution Prepared by

Annexure-II

Sanitization of Chlorine Dosing Tank

DateChemical UsedChemical Prepared byConc. of ChemicalSoaking  Time of  Tank & Dosing PipesDone byChecked by
FromTo
        

 

 

 

 

 

 

SOPs

Cleaning of Raw Material Store, Packing Material Store and Finished Goods Store

Posted on By ABHA

Objective

  • To lay down a procedure for Cleaning of Raw Material Store, Packing Material Store, and Finished Goods Store.

Scope

  • This Standard Operating Procedure is applicable for Cleaning Raw Material stores, Packing Material Store and Finished Goods Stores at the formulation plant.

Responsibility

  • Concerned Department personnel shall be responsible to follow the procedure mentioned in this SOP.
  • The concerned Department in charge shall be responsible for the implementation of the procedure mentioned in this SOP.

Accountability

  • The concerned Department in charge & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

  • SOP:            Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
  • Wet duster:            soaked with disinfectant solution
  • QA:            Quality Assurance
  • RM:            Raw Material
  • AHU:            Air Handling UnitMaterial

Procedure

  • Collect all the waste material, the dust settled over tables, floors, containers, furniture, fixtures & walls with the help of a vacuum cleaner.
  • Clean the door, window glasses, door closures, handles, and all the hinges of the door using clean dry duster followed by wet duster and again with a dry duster.
  • If a weighing balance is present in the processing room, clean it by using a wet duster followed by dry duster.
  • Clean the pallets, trolleys, etc. using a wet duster followed by a clean dry duster.
  • Remove the dust from the switchboards, utility pendants using the vacuum cleaner.
  • Clean the SOP stand using a clean dry duster.
  • Clean the accessories box using the wet duster followed by a clean dry duster.
  • Clean the ceilings of Air Handling Unit (AHU) supply/return grilles with a pipe brush and vacuum cleaner (if applicable).
  • Clean the ceiling of the whole area including racks, shelves using a wet duster followed by a clean dry duster.
  • Clean and mop the entire floor twice using disinfectant solution (2.5 % Dettol/Savlon) or any other disinfectant (if required) as per SOP.
  • Clean the tube light fixtures using a wet duster followed by a clean dry duster.
  • Clean the walls, coving, corners of the entire area using wet duster followed by clean dry duster.
  • Clean the cameras of the entire area using a wet duster followed by a clean dry duster.
  • Collect all the waste from the waste bin into a polybag and send it to the scrap area. Clean the waste bin with a wet duster followed by a clean dry duster.
  • Clean the drain points using the disinfectant solution.
  • Enter the cleaning activity details in the Area Cleaning Log Book.
  • Frequency: Twice a day or as when required

Forms and Records (Annexures)

  • Area Cleaning Log Book                              –                        Annexure-I

Distribution

  • Master copy          –    Quality Assurance
  • Controlled copies        –     Quality Assurance, Stores

History

DateRevision Number
Reason for Revision

Annexure-I

Sr No.Check PointDate       
ScheduleE
1.Cleaning of the entire floor using disinfectant solution (2.5 % Dettol/Savlon) or any other disinfectant (if required) as per SOP.
2.Cleaning of doors, window glasses, door closures, door handles, and all hinges of doors using dry duster followed by wet duster and again dry duster.
3.Cleaning of trolleys, pallets, etc. using wet duster followed by dry duster.
4.Cleaning of Weighing Balance if present using wet duster followed by dry duster.
5.Cleaning of accessories box using wet duster followed by dry duster.
6.Cleaning of switchboards, utility pendants using a vacuum cleaner.
7.Cleaning of walls, coving, racks, shelves, tube fixtures with wet duster followed by dry duster.
8.Cleaning of AHUsupply/return grills with a pipe brush and vacuum cleaner.
9.Cleaning of drain points using the disinfectant solution.
10.Cleaning of SOP stands with a dry duster.
11.Collection of all the waste from the waste bin into a polybag and transfer to the scrap room. Cleaning of waste bin with wet duster followed by dry duster.
Done By               
Checked By              

Note: All the observations of cleaning shall be recorded in the cleaning record. If the cleaning activity  is satisfactory write ‘OK’, if not satisfactory write ‘NOT OK’ and if  not applicable  write ‘NA’

SOPs

Stock Rotation of Raw Materials, Packing Materials and Finished Goods on the “First-in, First-out” basis

Posted on By ABHA

Objective

  • To lay down a procedure to ensure proper stock rotation of Raw materials, Packing Materials, and Finished Goods so that the stock rotation of the materials may be on the “First-in, First-out” basis.

Scope

  • This Standard Operating Procedure is applicable in Store for Stock Rotation of Raw Materials, Packing Materials, and Finished Goods on the “First-in, First-out” basis at the formulation plant.

Responsibility

  • Store personnel shall be responsible to follow the procedure mentioned in this SOP.
  • Store in charge shall be responsible for the implementation of the procedure mentioned in this SOP.

Accountability

  • Store Incharge & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

  • SOP:            Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
  • QA:            Quality Assurance
  • FIFO:            First In First Out
  • Finished Goods

Procedure

  • The persons holding charges of the stores of Raw Materials, Packing Materials and Finished Goods shall maintain their stores adopting a system to avoid the materials brought earlier may not remain in the store without disposal for a long time by dispatching the later ones.
  • The persons holding charges of stores shall adopt the procedure of the proper stock rotation of the materials stored by them on the basis of “First-in, First-out” (FIFO).
  • The materials shall be stored in such a way to enable quick identification and stock movement.
  • The stocks should be racked and stored in a manner that earlier stocks are more easily accessible than the later ones.
  • The stock received should be with proper documents detailing the name of material, the batch number, quantity received and date of expiry, if any.
  • The stock control system must be such that only passed lots (released) are issued.
  • The materials should be stored on shelves at convenient heights and with proper labels which clearly identify the materials and with status labels of “Released” on each packing.
  • List of materials giving details such as their names, batch numbers, date of manufacture and date of Expiry, if any, and quantities in stock, should be prepared.
  • The stock rotation shall be such that the materials are disposed of on the “First-in, First-out” basis, i.e. in sequence of their receipt to avoid disposal of any material received later than the one received earlier.

Forms and Records (Annexures)

  • Not Applicable

Distribution

  • Master copy         –   Quality Assurance
  • Controlled copies        –  Quality Assurance, Store

History

DateRevision Number Reason for Revision
–0New SOP

 

SOPs