Batch Document Review and Inprocess Checks SOP are essentially a way to ensure quality and consistency during the manufacturing process.

Here’s a simplified explanation:

1. Batch Document Review: Before making a batch of products, you review all the documents related to the manufacturing process. This includes recipes, instructions, and quality standards to ensure everything is correct and ready to go.
2. In-process Checks: While making the products, you perform regular checks to make sure everything is going according to plan. This could involve measuring ingredients, checking temperatures, or inspecting the product at different stages to catch any issues early on.

These steps help maintain quality control and ensure that the final products meet the desired standards.

OBJECTIVE  :

To establish a procedure for Inprocess and batch document review of products manufactured and finished products received.

SCOPE :

This procedure is applicable on Inprocess checks and batch documents review of the following:

1. Bulk granules
2. Bulk Tablets (Cores/Coated)
3. Bulk Capsules
4. Bulk liquids (liquid/suspension)
5. Bottle Pack Tablets/Capsules
6. Strips/Blister pack tablets/capsules
7. Plastic dispenser pack tablets (Canderel Tablets)
8. Plastic Jar powder pack (Canderel SFS)
9. Plastic Jar Pack (Vicks Vaporub/Danocrine capsules)
10. Filled glass bottle liquid / suspension
11. Plastic bottle liquid pack (Serenace Drops/Hibiscrub)
12. Ampoules/injection packs
13. Sachet packs (ORS/Canderel)
14. Batch Document Review and Inprocess Checks SOP

RESPONSIBILITY :

1. Quality Assurance Manager is responsible to implement the Work Instruction.
2. Laboratory Manager is responsible to arrange the testing of the inprocess and the final products.
3. Inspection Manager is responsible to arrange the inprocess and final inspection of the product.

PROCEDURE Batch Document Review and Inprocess Checks SOP:

Inprocess Inspection:

1. Quality Assurance Inspector to verify the cleaning of area and equipment in which product has been manufactured.
2. Quality Assurance Inspector to verify the manufacturing steps process duly signed by Operator / Production Supervisor.
3. Quality Assurance Inspector to verify the granules reconciliation / yield before giving the assign weight.
4. Quality Assurance Inspector to verify the area / Machine to be used for filling / compression including punches/tools.
5. Quality Assurance Inspector to verify and record the inprocess checks for tablets (Wt. variation, Disintegration Time, Friability, Hardness, Thickness) the inprocess control data sheet (QAD/IV/0039) and for sachet data to recorded the inprocess control sachet filling (Wt. Variation, Batch / Exp. Coding, Leakage test) (QAD/IV/0040).
6. Quality Assurance Inspector to collect and record individual weight variation of Tablets/ capsules in variables control chart (QAD/IV/0041) and plot the graph.
7. Quality Assurance Inspector to verify the area / machine to be used for coating of the tablets.
8. Quality Assurance Inspector to verify the coating process and physical appearance of the coated tablets during process.
9. Quality Assurance Inspector to verify the tablets reconciliation / yield after checking the final appearance, weight. At the time of sampling and record the inprocess data against inspection and sampling report for solids (QAD/IV/0042)
10. Quality Assurance Inspector to verify the area and machine to be used for bottle filling / striping / blistering of tablets/capsules.
11. Quality Assurance Inspector to check the blister/strips during process (Foil identification, PVC identification, Batch/Exp., alignment of tabs / caps in Strip / Blister, Leakage test) and record the results on inprocess control strip sealing form (QAD/IV/0043).
12. Quality Assurance Inspector to verify the packaging instruction component Assembly.
13. Quality Assurance Inspector to verify the packing line against line clearance record (QAD/IV/0044)) and line readiness checks record (QAD/IV/0045)
14. Quality Assurance Inspector to verify the batch coding (Batch No., Exp. Price) against label preparation form (QAD/IV/0046) and a specimen of label/carton duly signed and attached with this form.
15. Quality Assurance Inspector to check the whole packaging process against inprocess control data packing form (QAD/IV/0047)
16. Quality Assurance Inspector to verify the area and process vessels before start to the liquid manufacturing process.
17. Quality Assurance Inspector to verify the ingredient assembly sheet and the manufacturing steps/process duly signed by operator/production supervisor.
18. Quality Assurance Inspector to verify the volume make up, physical appearance, colour, flavour, taste, pH. At the time of bulk liquid sampling and record the inprocess data against inspection time and sampling and sampling Report for liquid (QAD/IV/0048)
19. Quality Assurance Inspector to verify the PRC for its completeness and correctness including yield.
20. Batch Document Review and Inprocess Checks SOP
21. Quality Assurance Inspector to verify the cleaning of area and filling line as per line clearance form, line readiness form and Label preparation form before the start of packing process.
22. Quality Assurance Inspector to verify the whole packing process against inprocess control data packing form (QAD/IV/0047)

Batch record review:

1. Quality Assurance Inspector to verify the batch record card manufacturing (PRD/IV/0005) and batch record card packaging (QAD/IV/0050) duly signed by responsible persons.
2. Quality Assurance Inspector to inspect the injection supply and prepare inspection report for injectables(QAD/IV/0051) after reviewal of batch documents supplied by manufacturer. The batch can directly transferred to ware house on the basis of manufacturer’s certificate of analysis. The GRN will be released on the basis of reference samples and related documents received.
3. Quality Assurance Inspector to verify the batch reconcilliation / yield data form (QAD/IV/0028) for tablets, for liquids (QAD/IV/0029) and for sachets (QAD/IV/0030); if yield is not within limits, justified comments from Production manager should be entered.
4. For final release of the product, Quality Assurance Inspector to verify complete batch document along with the certificate of Analysis and transfer note finished stock in batch document reviewal check list, QAD/IV/0072 for liquid products, QAD/IV/0094 for solid / semi solid products, QAD/IV/0101 for sachets and QAD/IV/0102 for injections.
5. For final release of the imported products, Quality Assurance Inspector to verify the batch documents including manufacturer’s Certificate of Analysis. The Batch Document Review and Inprocess Checks SOP product will then be ‘RELEASED” on the basis of Certificate of Analysis, Finished Identity and Inspection report.
6. A batch may be partly released, if all bulk chemical tests and finished pack tests conducted are satisfactory. In addition, the partial batch, after satisfactory packing, undergoes inspection by Quality Assurance in terms of all checks as applicable to the complete batch (as described in section QAD/IV/0018).
7. After approval from Quality Assurance Manager for dispatch, all the copies of transfer note are to be stamped with “RELEASE”; copy of transfer note to be retained along with the complete batch documents for filing, other two copies to Manager distribution and to accounts department.