QMS-090 Evaluation of Batch Documentation and Release for Sale

Document Owner

Quality Assurance Manager

Affected Parties

All Quality Assurance and Laboratory colleagues.

Purpose

To define procedures for evaluating Batch Documents for release for sale.

Scope

This SOP is to be followed by the Quality Assurance Staffs responsible for checking Batch Documents and retention samples.

Definition

Related Documents

EHS Statement

Protective eyewear and gloves should be worn when handling 70% IPA.

Care must be taken to avoid injury to personnel or damage to the sample.

Product packed in glass requires extra care to be taken.

QA staffs must observe clothing requirements when collecting samples (see SOP MAN-005)

Procedure

1.                 Summary of Evaluation of Samples and Batch Documents by QA

1.1.             Evaluation of each sample against Batch Documents for physical conformity.

1.2.             Evaluation of Batch Documents against their appropriate Checklists for completeness, correctness and conformance to reconciliation limits.

1.3.             Evaluation and completion of “QA Inspection Sheet” for conformity to specifications.

1.4.             Prioritization of urgent products.

1.5.             Recording of Deviation Report (DR) and other delays and filing of completed DR with Batch Documents.

1.6.             Final Release of Finished Product by Authorized QA Person (see SOP QMS-070).

2.                 Training of QA Staff

2.1.             Quality Assurance Staff who will be authorized to evaluate the batch documents must be adequately trained. Three (3) Batch Documents should be counter evaluated by the trainer to ensure eligibility of the QA Staff for correctness prior to batch document checking.

3.                 Receiving/Collecting of Samples

3.1.             The manufactured products of a BPN are placed in the retention Sample Room by production operators.  Samples are logged into the Test and Retention Samples Logbook (Form-560) by production staff. (See SOP MAN-120).

3.2.             There are two (2) types of samples:

a. Bulk samples: In-Process manufactured Goods, prior to packing.

b. Packed samples: These are samples in the Finished Goods pack.

3.2.1.       Bulk Samples

Bulk samples are delivered in a plastic bag and are accompanied by a Finished Product Specification and Test Report for the corresponding BPN. A Laboratory representative will collect these. Sample log book will be signed by laboratory staff.

3.2.2.       Packed samples

Packed Samples of a BPN are delivered in the final packs. Test and stability samples are to be collected by a laboratory Staff. Retention samples are to be collected by QA staff. The sample logbook (Form-560) is to be signed and dated on removal of the samples.

3.2.3.       Retention and test samples both come together.  For test samples, laboratory staff will remove the required test samples from the retention samples packs, leaving the rest for the QA staff to evaluate. Laboratory staff has to sign on the finished sample carton from which the test samples were taken. Then sign on the Sample Logbook (Form-560)

3.2.4.       Batch documentation should be received within 24 hours of completion of packing.

4.                 Receiving/Collecting of Batch Documents

4.1.             Batch Documents are delivered by production to the designated Batch Document office for each process area and are placed in the incoming tray labelled “Completed Batch Documents”.  Batch Documents are logged into the Batch Documentation Logbook, (Form-150) by production staff and must be signed and dated as logged out by the QA Staff before QA evaluation.

4.2.             Batch Documentation is to be evaluated by the authorized QA Staff in the Batch Documentation office.  Any Batch Documentation errors found are to be flagged by a Post-it note and placed into the Process Manager’s Red incoming tray labelled “Corrections”.  Process managers are responsible for checking the correction trays daily to ensure prompt resolution of errors.

NOTE: The use of ‘Post-it’ notes is restricted to the flagging of an error, there is to be no GMP information recorded onto the post-it note.  The ‘Post-it’ note is to be removed only by the QA Staff evaluating the batch documentation.

4.3.             Once the Batch Documentation error has been corrected, the Batch Documents are placed by production into the Green incoming tray labelled “Corrected Batch Documents” for collection by the QA Staff.  The QA staff will sign and date the Batch Documentation Logbook prior to removal from the office.

5.                 Evaluation of Batch Documents

5.1.             Batch Documents are checked against the appropriate “Batch Documentation Checklist” (Form-555) (see SOP QMS-085).  This checklist is printed by production and delivered with the Batch Documents.
NOTE: Use RED pen to perform all QA checks on the “Batch Documentation Checklist” Form.

5.2.             Check that Section 1 of the form is correctly filled up. Each document listed on section 2 of the checklist has been received and that all relevant paperwork is of the same BPN and the same manufacturing Material Code.  Write “N/A” on page 1 next to any documents not applicable to the BPN. Check any additional forms are attached with the MI sheet.

5.3.             Consult any SOPs listed above to ensure target limit results have been attained.

5.4.             Each page of each document received must be evaluated for accuracy and completion.

5.5.             Any issues with documentation that is less than the criteria listed below should be actioned as detailed in Section 4 above.

5.5.1.       A DR (See SOP QMS-035) must be raised if any of the following are noted during evaluation of Batch Documents:

5.5.1.1.  Critical entries have been left blank, e.g. missing signature on Line Clearance.

5.5.1.2.  Excessive, (i.e. greater than 5) non-critical entries are missing.
(A production operator may correct non-critical entries, e.g. missing one tick, without raising a DR.)

5.5.1.3.  An entry is recorded incorrectly and not corrected, e.g. incorrect date.

5.5.1.4.  Documents indicate there has been an absence of due care, e.g. illegible entries; multiple (greater than 5) entries marked as corrected by operators.

5.5.1.5.  Missing documentation, records or forms that cannot be recovered within 1 working day.

5.6.             Retention samples are evaluated (see Section 6.9) in the retention sample room.

6.                 Evaluating Manufacturing Instruction (MI) Sheet

6.1.             Check all phases are completed and signed off by authorised production person. Check for correctness and completeness of the MI sheet and relevant entries are made in accordance with GMP documentation ules. (See SOP QMS-020)

6.2.             MI Sheets “Comments section” must be read and understood.  If any DR is raised by the production personnel worked on the line, those DR numbers are to be recorded in the “Deviation report” section of the checklist.

6.3.             Check the following MI sheet entries are matching with the respective “Finished Product Specification” (TEM-145)

a. Batch number (BPN) (e.g. B XXXXXX)

b. Batch number format and coding on all packing components.

c. Expiry Date correctly calculated

d. Expiry Date format and coding on all packing components.

e. Correct product name and product number

f. Line clearance, line opening and cleaning entries are made properly and signed off.

g. Batch start up challenges are carried out and signed of.

h. All in-process checks are carried out according to procedure and signed off.

6.4.             Check the packaging Artworks are matching with the respective “Packaging Material Specification” (TEM-150)

a. Correct product name and strength/concentration on the packaging samples.

b. Correct storage condition and temperature is printed.

c. Correct graphics are printed on the packaging.

d. Correct quantity and/or volume are printed.

e. Other relevant artworks are matching with the regulatory specification.

6.5.             Check the following MI sheet entries are matching with the respective “Bill of Materials” (TEM-155)

a. Correct raw material code and description

b. Correct packaging component code and description

c. All components listed in the Bill of Materials are correctly issued, no component is missing. Check the attached Material Transfer Orders (see SOP QMS-085) for the issued components.

6.6.             Check the Reconciliation Sheet (Form-125) is correctly filed up with quantity received, quantity used and quantity returned for each raw material and packaging component. Check the reconciliation calculation for the raw material, finished product and packaging components are correct and within the limit (See SOP MAN-060).

6.7.             Check the pallet booking entries are correct and consistent on the MI sheet entries, Pallet booking Information form (Form-540) and on the Reconciliation sheet. Check the followings:

a. Number of booked out in the lot

b. Total finished product quantity booked out.

c. Good booking slip number

d. Check all pallet booking entries are signed off by authorize production personnel.

Quantity of Retention and Stability samples.

6.8.             Check the printed material sample sheet (Form-120) and examine all required number of  samples are attached, checked and signed by two authorized production operators according to SOP MAN-055. Check correct laboratory batch numbers are quoted on the printed samples.

6.9.             Check the correct quantity of retention samples are provided (See SOP MAN-120). Examine all retention samples physically for any defect or deviation from the requirement. Following are to be checked:

a. Correct BPN and code

b. Expiry date

c. Product Description and Strength/Concentration

d. Pack size

e. Check if there are leaflets enclosed if applicable

f. Check for security seals / holograms if applicable

g. Artwork check for FULLY packed product.

Retention samples are given to laboratory for storing according to SOP LAB-045.

6.10.         Authorized QA Staff has to print out a QA Inspection sheet (Form-565) and start to fill up the Part A of the form. Tick batch documents are conform to legal and GMP requirement. Than send the Inspection sheet to authorized Laboratory person to fill up the Part B of the form (See SOP LAB-065).

6.11.         Check all other additional forms and records for correctness of the batch document.

6.12.         Authorized QA Staff checking the batch documents has to fill up the section 3 of the Batch document checklist (Form-555). Sign and date the checklist before sending the checklist to Authorized QA person to Release the batch.

7.                 Recording of Deviation Report

7.1.             Check if any Deviation Report (DR) (Form-450) needs to be raised. Keep record of all the DR on the batch document checklist including the one raised by production personnel.

7.2.             Check if the deviations are Production deviation (DR1) and affecting the particular BPN (See SOP QMS-035).

7.3.             Send the DR to appropriate area managers for their response according to SOP QMS-035. No batch can be released until all Deviation Reports are successfully completed, implemented and recorded.

7.4.             After completion of process related (DR) attach one copy with the batch document. For all other deviations follow SOP QMS-035.

8.                 QA Inspection Sheet

8.1.             The QA Inspection Sheet (Form-565) summarizes all tests required according the Finished Product Specification and Test Report (TEM-145) and whither the results are within the specification. Authorized Laboratory Staff has to fill up the Part B of the Inspection Sheet, raised for the particular BPN, against the completed Finished Product Specification and Test report and sign the form to complete. Send the Signed Inspection sheet to QA for final release. (See SOP LAB-065).

9.                 Release of Batches

9.1.          Authorized QA Person responsible for batch release for sale will ensure the following before a batch is released for sale:

9.1.1.       Batch documents (completed MI Sheet, Forms and Records) are correctly checked for completeness and consistency.

9.1.2.       All in-process and finished product testing were done according to Finished Product Specifications and Test Report.

9.1.3.       Stability samples are taken according to stability program. Retention samples are correctly checked and managed.

9.1.4.       Batch documentation checklist (Form-555) is correctly checked, filled up and signed by both authorized production staff and QA Staff.

9.1.5.       QA Inspection Sheet (Form-565) is correctly filled up, signed and no data has inconsistency or no test result is out of specification.

9.1.6.       All Deviation Reports (Form-450) raised were successfully completed, corrective actions are implemented and preventative actions are listed.

9.2.             If all the actions are meeting the in-house and regulatory requirements, the Authorized QA Person will sign the Batch Document Checklist to release the batch.

9.3.             Authorized QA Person will produce appropriate number of RELEASED stickers, sign and send those to warehouse to labelled the pallets in Quarantine.

9.4.             For any unsuccessful inspection or non conformance authorized QA Person will hold the batch before the non-conformance is investigated (See SOP QMS-125) and the assignable cause will be determined.

9.5.             For any critical or serious defect or non-conformance authorized QA Person will reject the batch by stamping a RED reject stamp on the checklist and sign the form. Appropriate number of reject stickers will be produced and signed and send to warehouse to stick those onto the rejected pallets.

10.             Rework

10.1.         If a BPN is reworked, see SOP QMS-065 and ensure the following is received: Form-380 should be filled out by production and sent with relevant Batch Documentation again for evaluation and consequent release of the batch.

Summary of Changes