Follow
| 1 | Site Master File. |
| 2 | Air Quality Manuals. |
| 3 | Water Quality Manual. |
| 4 | All process-related SOPs. |
| 5 | Standard Testing Procedures (STPs) and Specifications for Raw Material, Packing Material, Intermediate, and Finished Product. |
| 6 | Market Complaints Record. |
| 7 | Calibration Record. |
| 8 | Process Validations report for 3 Batches. |
| 9 | Analytical Method Validations. |
| 10 | Cleaning Method Validations. |
| 11 | DQ/IQ/OQ/ PQ. |
| 12 | Internal Quality Audit Reports. |
| 13 | Medical Checkup Record of Employee. |
| 14 | Master Formula Records. |
| 15 | Batch Manufacturing Records. |
| 16 | Batch Packing Records. |
| 17 | List of Machine and Equipment for Production and QA/QC(QU- Quality Unit). |
| 18 | List of Competent Technical Staff. |
| 19 | Latest FDA Approved Plan. |
| 20 | Short Term, Long Term and Photostability. (Zone wise.) |
| 21 | Stability study evaluation (accelerated and real-time) for three batches, including batch size, batch number, product name, expiry dates, stability study condition (accelerated/real-time), drug name, and so on (as per Format-A) (At least a six-month timeframe for Accelerated Stability data and a year for other data.) At the time of initial submission, real-time stability data must be submitted.) |
| 22 | Approved Vendor List and Vendor Evaluation Record. |
| 23 | Employee Training Record. |
| 24 | Pest Control, Premises Maintenance Record (Sanitation, Cleaning ). |
| 25 | Cloth Washing and Laundering Record. |
| 26 | Preventative and Break Down Maintenance Record. |
| 27 | All other Records as per WHO GMP Guidelines. |
| 28 | Must include Annual product quality review (APQR) Growth promotion test evaluation. |
| 29 | Preservative efficacy testing. |
| 30 | Risk analysis and critical control point documentation |
| 31 | Rule 158B of the Drugs and Cosmetic Rules, 1945, requires proof of safety and effectiveness. |
| 32 | last inspection Date |
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