Skip to main content

What is Quality Assurance (QA)?

 Quality Assurance (QA) is a wide ranging concept concerning all matter that individually or collectively influence the quality of a product. It is the totality of the arrangement made with the object of ensuring that products are of the quality required for their intended use. 

The QA department is responsible for ensuring that the quality policies adopted by a company are followed. In some organization, QA serves as the primary contact with regulatory agencies and is the final authority for product acceptance (release) or rejection. 

QA to play a major role in the identification, preparation and implementation of the necessary standard operating procedures (SOPs) relative to the control of quality.

Where QA has responsibility for final product release, it must determine that the product meets all the applicable specifications and that it was manufactured according to internal standards and cGMPs. A second major responsibility of the QA department is the monitoring quality or audit function.

 QA function not only determines that the procedures are current and correct, but that properly trained operators are following them.

Comments

Popular posts from this blog

Schedule M series - Training

Training: Training is one of the important aspect in pharmaceutical industry.  Training are broadly categories as below: 1. Induction training  2. SOP training  3. On-job training and 4. Training on Regularly & other soft skills. Training is covered in all the cGMP guidance and auditors verify the person involved in manufacturing of drug product are well trained to execute his/her task. Schedule M also emphasized the importance of training hence, covered the following requirement on training. 1.1: Beside basic training on the theory and practice of GMP, newly appointed personal shall receive training to the duties assigned to them. 1.2: Company should provide training in accordance with a written training program for all personal whose duties take them into manufacturing area or QC. This training includes all the personal from the technical, maintenance and cleaning (house keeping) and for other personnel as required. 1.3: Continues training shall the provided and ...

Evaluation of Tablet

  GENERANL APPEARANCE Size, shape and thickness Size and shape:  Can be controlled by size and shape of punches and die of tablet compression machine. Tablet thickness (dimensional variation) related to: a)        Constant compression load:  Tablet Thickness varies with tab. weight, die fill and Particle Size distribution. b)       Constant die fill: Thickness varies with compression load. Tablet thickness can be measured by: Micrometer:  Measure individual tablet thickness (so accurate information on variation between tab.) Holding tray: measure total tab. thickness of 5-10 tablet with a sliding caliper scale (not accurate information provider on variation between tabs but overall estimation) to give more rapid readings. Shape: Shape of tablet influence the choice of tablet machine used with special slotted punches that run at lower speed than conventional punches that produce round tablets. Organ...

Good Laboratory practices and Requirements of Premises and Equipment's.

Good Laboratory Practices and Requirement of premises and Equipment's General Requirements:- a) The laboratory or the the organization of which it is a part must be an entity that is legally authorized to function and can be held legally responsible. b) Management ensures that the laboratory carry out its testing, calibration, validation, and all other technical activities in such a way as to meet Good Laboratory Practices (GLP) requirements.  c) The Quality manger shall prepare a schedule for technical audit of the laboratory for GLP compliance by an expert or experts appointed by the top-management other than the in-charge of the laboratory and shall ensures the maintenance of documented quality systems as per quality manual. Premises:- a) The laboratory shall be designed, constructed and maintained so as to prevent entry of insects and rodents besides cross contamination. b) Wall, floor and ceilings ( interior surface) shall be smooth and free from cracks and permits easy cleani...