Quality Assurance

Quality Assurance

Introduction : “Quality Assurance” is the sum total of the organized arrangements made with the object of ensuring that all drug substances & drug products are of the quality required for their intended use and that quality systems...

Formats for change control , deviation & categorization of changes.

Change Control FormDownload Excerpt- 1) Do not retain this form and forward to the next after completion of review.2) Put N/A where not applicable.3) Attach an additional sheet if required as annexure.4) Please specify the details...

QUALIFIED PERSONS AS PER EUROPEAN PHARMACEUTICAL REGULATIONS

Qualified person (QP):- It is a technical term used in European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use). The regulations specify that no batch of medicinal product can be released...

QUALITY RISK MANAGEMENT

Quality Risk Management (QRM) gives the possibility of determining the impact of a deviation in a process or product in an objective manner, in order to categorise it and facilitate its treatment. ICH Q9...

ANALYTICAL INSTRUMENT QUALIFICATION (AIQ)

AIQ is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to confidence in the validity of generated data. PHASES OF QUALIFICATION DESIGN...

HVAC SYSTEM VALIDATION TESTS

AIR FLOW PATTERN:- For determination of air flow pattern, a titanium tetrachloride stick is burnt and placed in front of the AHU. The distribution of smoke is observed. It should be uniform.   AIR FLOW VELOCITY...

DRUG REGULATORY AFFAIRS AND ITS COMMON TERMINOLOGIES

Regulatory Affairs:- Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration...

GUIDELINE ON RECALL

Introduction:- Recall is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy or safety. The defective products related to quality includes...

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