Explain raw material and in – process quality control . 

Explain raw material and in – process quality control . 

Ans . Raw Material Quality Control : Good raw material specification must be written in precise terminology , must be complete , must provide specific details of test methods , types of instruments and manner of sampling and must be properly identified .

The FDA , CGMP simply state that components be received , sampled and tested and stored in reasonable way that rejected material be disposed of , that sample of tested components be retained and the appropriate records of this steps be maintained . In practice manufacturer physically inspects and assigns lot number to all raw materials received and quarantine until they are approved for use.

Each raw material is sampled according to standard sampling procedures and is sent to the quality control lab for testing according to written procedures.

Any raw material not meeting specification must be isolated from the acceptable materials, stickered as a rejection and returned to the supplier or disposed of promptly.

Raw material are classified into two groups :

  1.  Active or therapeutic : They are mainly tested for solubility, identification, melting range, loss on drying, residue on ignition . Special melting testing, specific impurities that are related to method of manufacturing of individual raw material and assay
  2. Inactive or Inert : They are mainly tested for physical characteristic , chemical purity , particle size , heavy metal content , water content , microbial limit , foreign matter , pH and residue as ignition.

In Process Quality Control : It is an important function of the in – process quality assurances program to ensure that finished dosage forms have uniform purity and quality within a batch & between batches . This is accomplished by identifying critical steps in the manufacturing process and controlling them within defined limits.

It includes , sanitation program , extermination programs for rodents and insects , good housekeeping . Personal cleanliness and hair covering also needed . Floor walls should be resistant to external forces.

There should be a manufacturing working formula procedures for each batch size that is produced . Quality assurance personnel must review and check the working formula procedures for each production batch before , during and after production,

There should be proper identification by name and dosage form , item number , lot number , effective date of document , reference to a superseded version , amount , lot and code number of each raw material utilized.

A variable group of test that are widely used for in – process controls measure characteristic including physical appearance , color , odour , thickness , diameter , friability , hardness , weight variation , disintegration time , volume check , viscosity and pH.

Such in – process tests are designed to ensure quality control of problems that can arise during finished dosage form manufacturing .

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