QA department is well-handled by professional staff who have years of experience in this field. It ensures that the product manufactured adheres to specific standards and strives to continuously improve results and eliminate errors.
Overview of QA’s role:
- Development Stage – During R&D, checking the qualification of raw material, vendors, testing methods, validation, document control, equipment calibration and operating procedures, personnel recruitment and training, data recording, clinical trials, formulation of API batches, and more.
- Manufacturing Stage – These are a few examples of the QA unit’s role during production:
- Preparing, approving and monitoring the implementation of key documents (Quality Policy and Objectives, Quality Manual, etc.).
- Ensuring that specifications and test procedures for raw materials, packing materials, in-process testing, APIs, stability testing, etc. are all in place.
- Reviewing training records to check if on-the-job and induction training is taking place according to the schedule and whether QC (Quality Control) analysts are being validated.
- Ensuring that planned/unplanned changes or deviations are documented, reviewed and analysed, and recommending studies, tests or validation activities to be performed.
- Initiating, documenting and investigating market returns, reprocessing (for API batches) or destruction (for finished batches), and informing regulatory authorities about defects found, if any, after distribution.
- Reviewing and approving manufacturing records and QC testing data before any intermediate, API or finished batch is released, as well as periodic trending of this data.