SOP Title: Product Manufacturing Quality Plan
- Objective:
To lay down procedure for systematic work plan for quality control of product manufacturing process to assure specified product quality attributes.
- Scope:
This procedure is applicable to quality control plan for all stages of product manufacturing cycle i.e. RM/PM receipt, testing, storage, dispensing, batch manufacturing, packing and release.
- Responsibility:
Concerned Department: Responsible to follow the procedure for operation and control material/product at each stage.
QA Department: Responsible to prepare, review and approve the procedure and ensure that the procedures and control points are being followed.
- Accountability:
Head QA/All Department
- Procedure:
- Definitions:
- QA Associate: Executive/officer or any person trained of Quality Assurance Department as per this SOP.
- Production Associate: Executive/officer or any person trained of Production Department as per this SOP.
- QC Associate: Executive officer of Quality Control Department or the personnel trained to perform duties as per this SOP.
- Warehouse Associate: Executive officer of Warehouse Department or the personnel trained to perform duties as per this SOP.
- Procedure:
| 5.2.1 | All incoming materials shall be checked for physical damages, labelling and quantity requirements. Then the material shall be segregated as per the approved procedure, GRN & MCR of received material shall be sent to QC Department. | |
| 5.2.2 | Based on the GRN & MCR received from warehouse inspection and sampling of incoming material shall be performed and material shall be labelled with yellow colour “UNDER TEST” label. | |
| 5.2.3 | The sampled incoming material shall be entered in the laboratory log book (separate for Raw & Packing materials), analyzed by Quality Control Analyst with IP, BP, EP,USP or In-house Specification. | |
| 5.2.4 | The sample is analysed and all analysis results shall recorded in AWR (Analytical Work Record) log sheets and COA shall be prepared. | |
| 5.2.5 | Based on AWR, a report Raw Materials and Packing Materials shall be labelled with green (APPROVED) label or red (REJECTED) label depends on the status. | |
| 5.2.6 | A portion of API shall be retained as Control Sample as per approved procedure. | |
| 5.2.7 | Only Approved Raw Materials shall be dispensed and used for manufacturing process. | |
| 5.2.8 | Before start up of manufacturing process QA line clearance should be taken as per procedure to avoid contamination, cross-contamination and mix-up. | |
| 5.2.9 | During each stage of manufacturing respective product BMR/BPR shall be available. All the manufacturing processes shall be carried with relevant BMR and BPR. Manufacturing process shall be carried out in direct supervision of competent technical staff. | |
| 5.2.10 | During manufacturing initial and in-process checks shall be carried out as per product BMR/BPR. | |
| 5.2.11 | All process materials in the processing area should be stored in specified closed container with proper labels. | |
| 5.2.12 | Sampling of in-process product shall be carried and tested. After release of in-process bulk products, product shall be forwarded to further stage/activity. | |
| 5.2.13 | Testing of bulk material shall be carried out as per product specification. | |
| 5.2.14 | In case of any non-compliance, it shall be notified, investigated and corrected through proper documentation system. | |
| 5.2.15 | The Finished Product is sampled and tested as per IP, BP, EP, USP & In-house specification | |
| 5.2.16 | On analysis of the Finished Product, all data is recorded in Analytical work Record sheet. | |
| 5.2.17 | A portion of the Finished Product is retained as ‘Control Sample/Retention Sample’ and record shall be maintained. | |
| 5.2.18 | Based on the details of AWR, COA shall be prepared and copy shall be sent to QA. | |
| 5.2.19 | The finally packed Finished Goods shall be inspected and a final inspection report is prepared. | |
| 5.2.20 | The retained Control Samples are randomly checked for any physical changes and randomly batches are kept for stability. | |
| 5.2.21 | All batch related records shall be retained for a minimum period one year after expiry of the product unless there is any regulatory commitment. | |
| 5.2.22 | The Finished Product shall be inspected and released by the authorized person. |
- Abbreviation:
| Abbreviation: | Expansion |
| QA | Quality Assurance |
| QC | Quality Control |
| BP | British Pharmacopoeia |
| EP | European Pharmacopoeia |
| USP | United State Pharmacopeia |
| IP | Indian Pharmacopoeia |
| AWR | Analytical Work Record |
| MCR | Material Control Record |
| GRN | Goods Receipts Note |
*Note – Ready to use SOP available in “DOWNLOAD” Section.