Quality control system is engaged in sampling, preparation of specifications, testing of materials and products, preparation of documentation, preparation of raw & packaging material released procedures etc. Moreover, Quality Control Department has other duties to establish, validate (with Product development) and implement all quality control procedures, keeping the reference samples of materials and products, ensuring correct labeling of containers of materials and products. Besides these Quality Control activities include monitoring of stability of products (with product development) and participating in the investigation of product complaints.

The Quality Control Department has the responsibility and authority to sample, test and accept or reject all materials, such as, active substances, excipients, primary and secondary packaging materials. The Quality Assurance Department has responsibility and authority to sample intermediates and finished goods. To carry out these functions efficiently and effectively, adequate laboratory facilities are provided in a well-established chemical testing laboratory, along with a well-equipped instrumentation laboratory with modern sophisticated analytical equipments and a microbiology laboratory.

The Quality Control Laboratory facilities are designed equipped and maintained for efficient testing of raw materials, packaging, intermediates and finished products.

Staffs in the laboratory are qualified, trained and certified to analyze and document the results for raw materials, packing materials, intermediates and finished products.
 

Analytical instruments are calibrated at pre-determined intervals in accordance with the specified and approved calibration methods. The calibration status of each instrument is properly indicated. Calibration records are maintained, checked and approved by those in charge of the instrument and verified by sectional head.

Working standards used are carefully selected. They are standardized against reference standard by experienced analysts, so as to assess their suitability for use as a working standard. The storage conditions for the working standards, as well as their validity for use, are specified and all the relevant documents maintained.

Volumetric solutions used in assays and other tests are prepared from material of a suitable grade in accordance with the approved procedures. Standardizations are performed by experienced analysts so as to get concordance as per the approved procedure.

Quality control department assess the finished products covering all relevant factors including production conditions, results of in-process testing, review of batch manufacturing records and batch packaging records, compliance with finished products specification and examination of final finished packs.

The authority to approve and release a product batch is vested in the Quality Assurance Department and controlled by the Quality Assurance Manager. As soon as the packing operations are over, the completed Batch Manufacturing Record, which has been checked by the Head of Production or his designee, is handed over to the Quality Assurance Department. The Quality Assurance Manager or his designate reviews all entries and all other related documents pertaining to stores, quality control, quality assurance in-process checks of batch manufacturing and batch packing records etc.

If yield calculations at all stages and reconciliation are acceptable as per the laid down procedures, and Batch Manufacturing Record is complete in all respects, the Quality Assurance Manager releases the batch for distribution and sale after signing the BMR.

Quality Control Department has the responsibility for the preparation, revision and distribution of the following documents:

♦ Raw materials, Packaging material, Finished products specifications

♦ Analytical methods

♦ Batch analysis records

♦ SOPs and associated documents

♦ Certificate of analysis

♦ Validation data

A periodic review of the above documents are done to update/ revision of the documents based on any changes in the regulatory requirements, pharmacopeial changes and customer requirements as well as any situation arises due to any internal changes.