Review, Storage, Retrieve and Disposal of Executed Batch Documents

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1773

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

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