Objective
To lay down the procedure for Review, Storage, Retrieval and disposal of Executed Batch documents.
Scope
This SOP covers the procedures for Review, Storage, Retrieval and disposal of Executed Batch documents in pharmaceutical company
Responsibility
Quality Assurance /Officer and production chemist shall be responsible for following the procedure mention in this SOP.
Production mfg. chemist and QA executive shall be responsible for compliance of this SOP.
Accountability
Head Production and Quality Assurance accountable for 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
BMR : Batch manufacturing record
COA : Certificate of analysis
Procedure
- Check the executed BMR after completion of batch shall have containing all sheets as issued.
- Ensure that the following sheets are attached along with BMR that is Raw material requisition slip, Raw material issue note, Raw material issued to production (dispensing sheet), Packing material requisition slip, Packing material issue note, Packing material return from production, Packaging coding control record, manufacturing & packing process details, finished product analysis report, Product re-conciliation sheet, Post- batch line clearance record (QA), Release order and finished Goods Transfer Note.
- Review the recording of entire activity in BMR and verify the data in calculations & reconciliation of the manufacturing and packing operations in the respective documents.
- Ensure that all activities of the process operations has been recorded as specified in documents and no place for recording or verification is left unaddressed. Verify that entries are made for “Done By” & “Checked By” for different activities and timings are entered accordingly.
- Check and verify the yield reconciliation at respective stages of the processing as shown in BMR with respect to inputs and expected standard yields.
- Ensure that yield at various stages are within the specified limits. Any deviation from specified limit for yield is investigated, and yield deviation report is approved by QA Manager.
- Check and verify the primary, secondary packing material as shown in BPR. Ensure that any deviation from specified limit is investigated and approved by QA Manager.
- Ensure that in process checks during manufacturing and packaging are properly documented and are found within specified limits.
- Verify the COA with respect to their respective specifications of the final analysis of finished products.
- Compile the Batch manufacturing and packing records along with the analytical documents, in-process reports.
- Punch all components and enclosures of the BMR & COA kept together.
- Ensure that BMR are stored in the Documentation Room under locked conditions and the key is available with the Documentation Executive / Officer & QA Manager.
- Ensure that the BMR are accessible to person other than QA Executives / Officers only after authorization from the QA Manager.
- Ensure that BMR are preserved for a period of 01 years from the date of expiry of the batch.
- After the storage period of BMR is over, the documents are shredded in a paper shredding machine in the presence of QA Executive / Officer but only after an authorization from QA Manager.
- Forms and Records (Annexures)
- Checklist of attached review documents – Annexure-I
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control, Stores.
9.0 History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure – I
| Product : | B.No. : | B.Size: | |||||
| Date of Mfg. | Date of Exp. | ||||||
| S. No | Particular | OK | Not OK | NA | Remarks | ||
| 1.0 | Check the Executed of Batch Manufacturing record (BMR) are containing all sheets as issued. | ||||||
| 2.0 | Line clearance checklist of all stage | ||||||
| 3.0 | Raw material requisition slip | ||||||
| 4.0 | Raw material issue note | ||||||
| 5.0 | Raw material issued to production (dispensing sheet) | ||||||
| 6.0 | Packing material requisition slip | ||||||
| 7.0 | Packing material issue note | ||||||
| 8.0 | Packing material return from production | ||||||
| 9.0 | Packaging coding control record | ||||||
| 10.0 | Manufacturing & packing process details | ||||||
| 11.0 | (A) For Ointment | ||||||
| 11.1.1 | Bulk product preparation & sampling | ||||||
| 11.1.2 | Bulk product analysis report | ||||||
| 11.1.3 | Filling and crimping of tubes | ||||||
| 11.1.4 | In-process control record | ||||||
| 11.1.5 | Packing & FG sampling | ||||||
| 11.1.6 | In-process packing control record | ||||||
| 11.2 | (B) For Tablets | ||||||
| 11.2.1 | Dry blending & granulation | ||||||
| 11.2.2 | Wet screening and drying of granules | ||||||
| 11.2.3 | Lubrication & bulk sampling | ||||||
| 11.2.4 | Bulk product analysis report | ||||||
| 11.2.5 | Tablets compression record | ||||||
| 11.2.6 | In-process control record | ||||||
| 11.2.7 | Tablets coating record | ||||||
| 11.2.8 | Blistering, packing and FG sampling | ||||||
| 11.3 | (C) For Syrups | ||||||
| 11.3.1 | Sieving, mixing and bulk sampling | ||||||
| 11.3.2 | Bulk product analysis reports | ||||||
| 11.3.3 | Cleaning & inspection of cleaned bottles | ||||||
| 11.3.4 | Filling, sealing ,labeling and inspection | ||||||
| 11.3.5 | In-process weight check record | ||||||
| 11.3.6 | In-process weight check record | ||||||
| 11.3.7 | Packing and FG sampling | ||||||
| 11.3.8 | In-process packing control record | ||||||
| S. No | Particular | OK | Not OK | NA | Remarks |
| 11.4 | (D) For Injection area | ||||
| 11.4.1 | Washing and sterilization of ampoules/ vials | ||||
| 11.4.2 | Washing & sterilization of rubber stoppers/ filling nozzles/ pumps etc. | ||||
| 11.4.3 | Mixing ,homogenization & filtration | ||||
| 11.4.4 | Blending & bulk sampling | ||||
| 11.4.5 | Bulk product analysis report | ||||
| 11.4.6 | Filling & sealing record | ||||
| 11.4.7 | Volume / weight check record | ||||
| 11.4.8 | Terminal sterilization of finished product | ||||
| 11.4.9 | Visual inspection duty | ||||
| 11.4.10 | Visual inspection of filled amps./ vials | ||||
| 11.4.11 | Labelling, packing and FG sampling | ||||
| 11.5 | (E) For Oral liquids | ||||
| 11.5.1 | Mixing, homogenizing and bulk sampling | ||||
| 11.5.2 | Bulk product analysis report | ||||
| 11.5.3 | Washing and inspection of washed bottles | ||||
| 11.5.4 | Filling ,sealing, labelling and inspection | ||||
| 11.5.5 | In-process volume check record | ||||
| 12.0 | Finished product analysis report | ||||
| 13.0 | Product re-conciliation sheet | ||||
| 14.0 | Final yield | ||||
| 15.0 | Post- batch line clearance record (q.a.) | ||||
| 16.0 | Release order |
Review by (Production) Checked by (QA)
Sign/Date Sign/Dates
