DESCRIPTION OF THE QUALITY CONTROL SYSTEM AND OF THE ACTIVITIES OF THE QUALITY CONTROL DEPARTMENT. PROCEDURE FOR THE RELEASE OF PRINTED COMPONENTS AND FINISHED GOODS.

The quality Control Department is part of the Quality Assurances Department. It is headed by a Quality Control Manager. The major activities of the quality control department are: 

• Approval / Rejection of raw and packaging materials (as per SOP)
• Testing of In-process samples (as per SOP)
• Testing of finished goods (as per SOP)
• Carrying out stability studies (as per SOP)
• Testing of water (as per SOP)

Procedure for Release of Finished Products:

As soon as any batch has been finally packed, the In-process Quality Control Personnel draw random samples of the finished product. These specifications are normally more stringent that the Pharmacopoeial requirements. If the random samples meet the specifications (known as product release specifications). The Quality Control Department certifies that the goods meet the laid down specifications.

The batch manufacturing Record is then reviewed by the Quality Control Manager. He checks for the completeness of the document and for the compliance with GMP’s at various steps. The Quality Control Manager releases the batch for distribution by signing Release Order.

The procedure for Release of Printed Packaging Material:

All printed packaging materials on receipt from vendor are stored in godown with Under Test status. A Goods Receipt note for the material is made and sent to Quality Control Department. On receipt of the good Reference Number to the material and does sampling of the same as per SOP on Sampling. Samples are tested as per the approved specifications & standard Test Procedures. If the samples confirm to the specification. Then the consignment is released and an ‘Approved’ label is pasted over the ‘Under Test’ label. The consignment is then moved to the ‘Approved Section’.

Specifications and Standard Test Procedures (STPs):

Specifications and STPs are prepared by Q.C. Department, as per Indian Pharmacopeia & other known test procedure books and finally reviewed by the Quality Control Department. In case of regulatory specifications and STPs, Department of Regulatory affairs is consulted.

Specifications and STPs are written in prescribed format with identification no, effective date and approval signatures. These are updated on any change in regulatory requirements or pharmacopoeias or change in specifications and STPs issued by various regulatory authorities.

Self Inspection & Quality Audits:

Self-inspection and quality audit is carried out with the objective to detect any shortcomings in the implementation of GMP’s and recommending the necessary corrective actions. There is a team of Quality Control Manager Production Manager, headed by Director of the firm for self-inspection. Such inspections are carried out as per defined procedure once in a month.

Vendor Development:

All starting materials are procured from approved vendors in case of a new supplier, audit of the site is undertaken by the quality control Incharge and the technical partner and both technical and commercial strengths of the supplier are judged using standard checklist. A part form this, there is a system for routine audit assessment of existing suppliers on continuous basis. Similar practice is followed for suppliers of printed packing materials also.

Contract Manufacturing & Analysis:

• Description of the way in which the GMP compliance of the contract acceptor is assessed
  No contract manufacturing of products is undertaken hence, is not applicable.
• Assessment of Ability of the Contract Laboratory
  Since no Contract Manufacturing is undertaken for products (b) is not applicable.