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 user departments as specified in SOP at Pharmaceutical Company.
RESPONSIBILITY
- It is the responsibility of the person whoever identifies a deviation, to record the event and to forward it to their respective department head. This is an activity for which all members of staff have a responsibility.
- Responsible Person
-
- Initiator (Person who identifies the deviation)
- Department Head
- Manager-Quality Assurance
-
ACCOUNTABILITY
- Manager-QA.
PROCEDURE
- A deviation is an activity performed or occurred either planned or unplanned in a different or modified form from specified manner.
- Planned Deviation: Any deviation from documented procedure opted deliberately for temporary period to manage unavoidable situation without affecting the quality and safety of drug substances or drug product shall be termed as planned deviation.
- Unplanned Deviation: Any deviation occurred in unplanned manner due to system failure or equipment breakdown or manual error shall be termed as unplanned deviation.
Classification of deviation
- Deviations are classified as Critical, Major and minor.
- Critical: Deviations related to defective / dangerous / potentially life-threatening that predictably or probably could result in Risk to product quality, safety, efficacy, regulatory compliance.
For example (But not limited to): wrong product (Label and contents are different), correct product but wrong strength, with serious medical consequences, wrong active ingredient in a multi-component product, mix-ups of some products, Foreign matter in pack.
- Major: Deviation from manufacturing/packaging instructions without any risk to product quality, safety efficacy.
For example (but not limited to): Mislabeling (Wrong or missing text or figures) Missing or incorrect information (leaflets or inserts) chemical/physical contamination Non-compliance with the specification, low assay, failure of dissolution rate, marked change in description.
- Minor: Minor breach of cGMP requirements, changes required during manufacture or testing of a product without affecting the product quality.
For example Reconciliation error, Visual/cosmetic defects, Remixing, re-milling, reinforcing an active ingredient, etc.)
Documents covered under the scope of this standard operating procedure include the following, but are not limited to:
-
- Standard Operating Procedures
- Manufacturing Procedures
- Packing Procedures
- Cleaning Procedures
- Environmental Monitoring
- Batch analysis (In-Process Control)
- Quality control testing
- Utility Operations
- Calibration Procedures
- Analytical Procedures
- Stability Procedures
- No process deviation should be permitted under normal operating conditions however in case the deviation is unavoidable; the same should be immediately brought to the notice of Manager-QA.
- No deviation shall be permitted from Pharmacopoeia and other Regulatory specifications.
- Before initiating the deviation, an evaluation shall be done to assess whether the deviation has any quality impact or quality non-impact
Quality Impact occurs during execution of an activity which will affect the quality, purity, or strength of the drug product.
Quality Non-impacting occurs during execution of an activity which will have no impact on the quality, purity, or strength of the drug product.
Only the deviation which is quality non-impacting in nature can be allowed with corrective actions.
Planned continuous deviation may be incorporated as Documentation change through appropriate change control
- The initiator shall indicate the deviation and mention the stage of operation in the deviation report along with the immediate proposed corrective action in consultation with department head and the deviation report shall be forwarded to QA department.
- QA designated representative shall evaluate the deviation with respect to the impact on quality and propose a suitable corrective action based on the nature of deviation.
- QA designated representative shall approve the deviation and assign the number.
- QA designated representative shall forward the report to Manager-Quality Assurance for authorization. The Manager-Quality Assurance shall review the report with their own recommendation if required, in the remarks column. VP-Plant & Operations shall give the final approval for remedial action.
- In case of deviation related to the products of contract giver, the deviation shall be immediately brought into the notice of Qualified Person of contract giver through e-mail or fax.
- The deviation shall be approved or rejected based on the recommendation of qualified person of contract giver.
- The report shall then be forwarded to concerned department as applicable based upon the nature of deviation.
- The department head shall ensure that the authorized remedial actions are implemented. Quality assurance shall retain the original for records irrespective of the approved/reject status of the deviation report, and a photocopy of the same shall be filed with the subjected batch processing/packing record or analytical reports.
- Wherever a deviation could affect multiple batches, e.g. due to equipment or facility failure or material or process deviation report, a photocopy of the same shall be filed with the subjected batch processing/packing record or analytical report.
- QA designated representative shall maintain summary of Deviations, Department wise, every year in a logbook. Deviation Control procedure closed within 30 days.
- Deviation Log shall have the following information
Deviation Number
Material / Product/ A.R. No. / Batch No. / If any
Nature of Deviation
- Deviation control numbering system:
XX D 001 / 20
Year Code i.e. 20 for 2020
Slash
Sr. No. of Deviation
Deviation code prefix
Company Code
- First Two characters are alphabets, which shall identify the orientating company code.
- Third character is alphabet “D” stands for Deviation.
- 4th, 5th & 6th characters are numeric shall indicate the Deviation Report number in the current financial year.
- Example: 001 for 1st Deviation
- 7th Character is “/” used as separator.
- 8th and 9th characters are numeric and shall represent the last two digits of the current financial year.
- Example: 20 for the year 2020.
- Deviation flow chart is referred at Appendix –I.
ABBREVIATIONS
- QA – Quality Assurance
- SOP – Standard Operating Procedure
Attachments :
| Sr. No. | Title | Format No. |
| Deviation Control Log | ||
| Deviation Control Form |
DISTRIBUTION LIST
| Sr. No. | Copy No. | Department |
| Quality Assurance | ||
| Quality Control | ||
| Quality Control – Microbiology | ||
| Production | ||
| Engineering & Utility | ||
| Personnel & Administration | ||
| Warehouse |
Attachment – I
DEVIATION CONTROL LOG
| Sr. No.
|
Date | Deviation Number | Material/Product
Batch No./AR. No. |
Nature of Deviation | Sign/Date
QA |
Closing Date
|
Attachment –II
DEVIATION CONTROL FORM
| Deviation No. | Date | ||||
| Nature of Deviation | Planned Unplanned | ||||
| Type of Deviation | Critical Major Minor | ||||
| Name of material/
Product/System: |
Batch Size: | ||||
| Batch No. | Other details if any | ||||
| Mfg. Date | Proposed date for closure: | ||||
| Exp. Date | |||||
| Description of Deviation: | |||||
| Noted / Proposed By: (sign & Date) |
|
||||
| Reason for Deviation: | |||||
| Manager Concerned Department
( Sign & Date) |
|||||
| Comments of any other Dept.: | Applicable / Not applicable (Write Yes or no) | ||||
| 1. Quality Control | Manager QA (Sign & Date) | ||||
| 2. Production | |||||
| 3. Warehouse | |||||
| 4. Personnel & Admin. | |||||
| 5. Engg. & Utility | |||||
| 6. VP –Plant & Operations | |||||
| 7. Contract giver | |||||
| Quality Control | |||||
| Manager-QC ( Sign & Date) | |||||
| Production | ||
| Manager Production ( Sign & Date) | ||
| Warehouse | ||
| Manager Warehouse ( Sign & Date) | ||
| Personnel & Admin. | ||
| Manager P&A ( Sign & Date) | ||
| Engineering & Utility | ||
| Manager Engineering ( Sign & Date) | ||
| VP-Plant & Operations | ||
| VP-Plant & Operations ( Sign & Date) | ||
| Comments / Suggestions from Contract giver (If Applicable) | ||
| Contract Giver ( Sign & Date) | ||
| Corrective Action |
| Preventive Action | ||
| Manager Concerned Department (Sign & Date) | ||
| QA Evaluation (Impact Assessment) | ||
| Manager QA ( Sign & Date) | ||
| Implementation details | ||
| Manager QA ( Sign & Date) | ||
| Closure Date/ Remark by VP-Plant & Operations :
The deviation is closed, based on the verification of the activities performed, recommendations followed and satisfactory review of all the relevant documentation. |
||
| VP-Plant & Operations ( Sign & Date) | ||