Quality Control

Effective System

We have a highly effective Quality Control system that encompasses activities of     both manufacturing and Quality Control Departments. The procedures & specifications include Master Formula Records such as Formula cards, Standard Operating Instructions, Work instructions, Raw Material Specifications, Standard  Packs  &  Specifications and  Finished  Product  Specifications etc.

Batch Manufacturing Records are based on the Master Formula Cards. Batch Manufacturing Records are maintained as per the rules laid down under Drugs & Cosmetic Act, 1940.

Over and above in-process checks carried out by Production Department and the routine quality analysis at various stages, we are also having a well laid down system of Quality Control. The Q.C inspectors keep a constant vigil on various manufacturing activities and carry out independent critical in-process Tests. The batch is released for marketing only after it is certified by the  Quality Control and Quality Assurance Departments. Moreover, the In-process report becomes a part of Batch Manufacturing Records.

How it Works

Quality Control Department samples tests all raw materials, packing materials as well as finished products as per the laid down specifications. The department is also responsible for generations, revision and distribution of all specifications and documents pertaining to manufacturing finished products and Quality Control (R.M.S & F.P.S) areas.

Besides this, a very important function of the Quality Control Department is to ensure strict adherance to Schedule 'M' of the Drugs and Cosmetics Rules, 1945, with respect to all activities carried out in the premises. The Quality Control department reviews the quality of all the marketed products on a regular basis and maintains the records of the same. The Quality Control department analyse, each and every batch of all finished products prior to its release in the market.

On completion of analysis and on compliance with specifications and various in-process checks, Quality Control department scrutinizes Batch production processes were carried out according to laid down process/ procedure and after ascertaining documentation of the same in Batch manufacturing Records, Quality Control Department issues " Market Release Slip" to distribution department and stamps "Released" on the Batch Manufacturing Records. Now the batch is ready for distribution and dispatch.

Quality Control shall be concerned with sampling, specifications, testing, documentation, release procedures which  ensure  that  the  necessary  and relevant tests  are  actually  carried  and  that  the  materials  are  not  released  for  use , nor products  released  for  sale  or  supply  until  their  quality  has  been  judged  to  be satisfactory.  It  is  not  confined  to laboratory operations  but  shall  be  involved  in all  decisions  concerning  the  quality  of  the  product.  It  shall  be  ensured  that  all quality  control  arrangements  are  effectively  and  reliably  carried  out.  The department  as  a  whole  shall  have  other  duties  such  as  to  establish, evaluate  , validate  and  implement  all Quality  Control  Procedures  and  methods.

The DOs of Quality Control

Every manufacturing establishment shall establish its own Quality  Control Laboratory manned by qualified and experienced  staff.
The area of the Quality Control Laboratory may be divided into Chemical, Instrumentation, Microbiological and Biological testing.
Adequate area having the required storage conditions shall be provided for keeping reference samples. The Quality Control department shall evaluate, maintain and store reference samples.
  • the designated name of the product and the code reference
  • the formula or a reference to the formula and the pharmacopoeial reference
  • directions for sampling and testing or a reference to procedures
  • a description of the dosage form and packge details
  • the qualitative and quantitative requirements with the acceptance limits for release
  • the storage conditions and precautions where applicable, and  
  • the shelf - life

QC Records are maintained regarding:

  • Receipt  of  materials
  • Sampling
  • Batch  numbering
  • Testing
  • Records of Analysis
  • Reference Samples
  • Reprocessiong & Recoveries
  • Distribution Records
  • Validation & Process Validation
  • Product Recalls
  • Complaints & Adverse Reactions