How to know about Quality Control department Role and Responsibilities


* It is a procedure to ensure that the manufacturing products to a defined set
  of quality criteria.

* Quality control is that part of GMP concerned with sampling, specification,
  testing, documentation and release procedures.

* Which ensure that the necessary and relevant tests are performed and the
  product is released for use only after ascertaining its quality.

* Resources: Adequate facilities
             Qualified personnel
             Approved written procedures.

* Tasks: Sampling
      Inspecting
              Testing
              Releasing or Rejecting
              Monitoring

* Objects: Starting materials
                 Intermediates
                 Bulk and Finished products
                 Returned products
                 Environmental conditions.

* Role and Responsibilities:

* Examines approves or rejects incoming materials, intermediates, bulk, finished products
  and returned products.

* Does the inspection during production(in process control).

* Establishes standardizes and implements all QC procedures and also establish the specification of each incoming materials.

* Establishes specification of intermediates, bulk, and finished goods together with the head of the production department.

* Approves reprocessing instruction and rework instruction.

* Reviews production records to determine errors and ensure that investigations have been conducted and the corrective action takes place.

* Involves in all decisions concern with the product quality.

* Establishing verification and implementing all QC procedures.

* Evaluating, maintaining, storing and monitoring all reference standards and
  retained samples.

* Reviewing Batch documentation.

* Stability testing of each finished products.

* Maintaining correct specification of materials and finished products.

* Participating in - Complaint investigations
                             - Environmental monitoring
                             - Gmp training.

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