STANDARD OPERATING PROCEDURES DURING MANUFACTURING:
There are some standard operating procedures that are to be followed before starting a batch. It includes cleaning and sanitation, setting up of machine, precautions to be taken before starting production, checks to be done before and during manufacturing process. These procedures are validated periodically as and when changes are necessary.
STANDARD OPERATIONS PROCEDURE FOR VALIDATION:
All the batches manufactured, should be complied with the conditions specified in the current Master Formula Card. Deviations, if any, must be mentioned where ever necessary.
Analysis of the product/process is as under .
Tablets Capsules
- Weight Variation: - Filled weight of the capsules
- Disintegration: - Disintegration time
- Assay: - Assay
- Dissolution: - Dissolution time
- Other related tests of the product: - Other related tests of the product
Each batch shall comply with the criteria specified by IP/BP/USP for product validation
The test results are tabulated. If they fall within specifications they are accepted, otherwise through analysis of the conditions/process in that particular batches would be analyzed, and related changes would be made. After this the process is revalidated. |