Month: January 2021

Chlorzoxazone ,Nimesulide Tablet                                                

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Chlorzoxazone ,Nimesulide Tablet PURPOSE:  This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form. SCOPE: This MFR is performed and is applied during the manufacturing of dosage form. RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The … Read more

Procedure For Terminal Inspection

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STANDARD OPERATING PROCEDURE Title : Procedure For Terminal Inspection  Department : Quality Assurance  OBJECTIVE To lay down the procedure for Terminal Inspection. SCOPE This procedure is applicable for terminal inspection and transfer of finish goods activities during processing of product. RESPONSIBILITY Officer-Production Officer-IPQA/QA ACCOUNTABILITY Manager-Production Manager-Quality Assurance PROCEDURE Terminal inspection procedure includes the verification of … Read more

Procedure For sampling of in-process product

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STANDARD OPERATING PROCEDURE Title: Procedure For a sampling of in-process product Department : Quality Assurance OBJECTIVE To lay down the procedure for sampling of in-process product. SCOPE This procedure is applicable to production and QA departments for sampling of in-process products for various stages of Tablet, Capsule and liquid products. RESPONSIBILITY Officer/Executive – IPQA – … Read more

Procedure For destruction & recovery generated during production

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STANDARD OPERATING PROCEDURE

Title: Procedure For destruction & recovery generated during production

  • OBJECTIVE 
    • To lay down the documented Procedure for destruction & recovery generated during  production the following recover are generated.
  • SCOPE
    • This SOP is Applicable for destruction & recovery generated during production the following recover are generated.
  • RESPONSIBILITY
    • Executive – Engg. & Utility.
    • Manager-Production.                                                                                                         
  • ACCOUNTABILITY
    • Manager-Quality Assurance 
  • PROCEDURE
    • PVC/PVDC Net
    • Foil Net
    • Label
    • Carton
    • Liquid, tablet, capsule etc.
    • Rejected or obsolete foil, labels, crotons, leaflets
    • The left over net and PVC/PVDC is collected and sent to the scrap yard for the authorized scrap dealer.
    • Obsolete foil is pierced with an Iron rod to make it unusable and to the scrap yard for the authorized scrap dealer.
    • The rejected labels, crotons, leaflets are from into piece manually verified by QA & sent to the scrap yard for sale to authorized dealer.
    • The blister/strip is defoiled to remove the tablets and the net is sent to the scrap yard for the authorized scrap dealer.
    • The power rejected tablets, capsules are put in to water in a Plastic drum  and mixed in water the supernatant liquid Is drained. The left over wet powder is collected a taken to the ETP for treatment.
    • The sludge, after ETP treatment is collected this sludge carried away by a government agency from the factory premises on a fortnight by basis.
    • ABBREVIATIONS
    • ETP – Effluent Treatment plant.
    • QA            –           Quality Assurance.
  • ATTACHMENT
Sr. No. Title  Attachment No.
Material Destruction & Recovery Log
  • DISTRIBUTION LIST
Sr. No. Copy No. Department
1 1 Quality Assurance
2 2 Quality Control
3 3 Quality Control – Microbiology
4 4 Production –
5 5 Engineering & Utility
6 6 Personnel & Administration
7 7 Warehouse
8 8 VP-Plant & Operations

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Procedure For the handling of rejected material

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     STANDARD OPERATING PROCEDURE  Title : Procedure For the handling of rejected material Department: Quality Assurance                                                    OBJECTIVE To lay down a procedure for defining the handling of rejected material. SCOPE This procedure is applicable for segregation the rejected material such as primary and secondary packaging material, raw material, and any type of finished product. … Read more

Procedure For BMR,BPR Review and Release

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STANDARD OPERATING PROCEDURE Title  Procedure For BMR, BPR Review and Release OBJECTIVE To define the procedure for review of the Batch Manufacturing Record and Batch  Packing Record. SCOPE This procedure applies to Quality Assurance Department. RESPONSIBILITY Officer / Executive – Quality Assurance ACCOUNTABILITY Manager – Quality Assurance PROCEDURE Executive – Production to review and ensure … Read more

Procedure For Deviation control system

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STANDARD OPERATING PROCEDURE Title : Procedure For Deviation control system Department: Quality Assurance OBJECTIVE To lay down the procedure for reporting and monitoring of deviations that occur during receipt and storage of material, manufacturing process of a product, testing and release of material/product, documented procedures wherever applicable. SCOPE This Procedure is applicable to all related … Read more

Procedure For Document Storage Period

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Procedure For Document Storage Period STANDARD OPERATING PROCEDURE Title :   Procedure For Document Storage Period OBJECTIVE   To define the procedure for Document Storage Period. SCOPE This procedure is applicable to Quality Assurance Department. RESPONSIBILITY Officer-Quality Assurance Executive-Quality Assurance ACCOUNTABILITY Manager-Quality Assurance PROCEDURE The Batch Manufacturing Records and Batch Packing Records along with all … Read more

Procedure For Annual Product Quality Review

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Procedure For Annual Product Quality Review STANDARD OPERATING PROCEDURE Title : Procedure For Annual Product Quality Review OBJECTIVE    To lay down a procedure for Annual Product Quality Review. SCOPE This procedure is applicable to Quality Assurance Department for annual product review of finished products . RESPONSIBILITY Executive-Quality Assurance ACCOUNTABILITY Manager-Quality Assurance VP – Plant … Read more

Procedure For Product Recall

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  Procedure For Product Recall STANDARD OPERATING PROCEDURE Title : Procedure For Product Recall          OBJECTIVE To lay down the Procedure for product recall. SCOPE This Procedure is applicable for Handling of Product Recalls at Pharmaceutical Company. RESPONSIBILITY It is a Joint responsibility of the Marketing Department in coordination with Quality Assurance Head-Export / Company Appointed Business agent of the country in coordination with Quality Assurance. Manager – Quality Assurance ACCOUNTABILITY Manager-QA VP-Plant & Operations. … Read more