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QA & QC

Meanings of terms

Meanings of terms Alcohol: The term “alcohol” without qualification means ethanol (95 percent). Other dilutions of ethanol are indicated by the term “ethanol” or “alcohol” followed by a statement of the percentage by volume of ethanol (CZH60) required. Desiccator: A tightly closed container of suitable size and design that maintains an …

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HACCP VALIDATION REPORT

HACCP VALIDATION REPORT LIST OF CONTENTS S. No. CONTENTS PAGE No. 1.0 Objective 2.0 Scope 3.0 Reason for Validation 4.0 Responsibility 5.0 Procedure for Validation 6.0 Sampling Plan 7.0 Data Recording 8.0 Acceptance Criteria 9.0 Deviations 10.0 Conclusion and Recommendation OBJECTIVE: HACCP validation is the element of verification focused on …

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HPLC (Questions & answers)

Q.1- What is the difference between the C8 and C18? Answer: – C8 has 8 carbon atoms and C18 has 18 carbon atoms, C18 is more hydrophobic than C8 due to that C18 has a long retention time and C8 has a sort retention time (early). Q.2- What is the …

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Dissolution (Question & Answer)

Dissolution (Question & Answer) 1. Question: What is dissolution? Answer:  Dissolution is the time require to release the active drugs substances into liquid form in a dissolution medium under setup conditions (RPM, Time, and Temperature). 2. Question: What is USP chapter No. for Dissolution? Answer: USP chapter No, <711> 3. …

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Interview Questions & Answers (Quality Assurance)

Interview Questions & Answers (Quality Assurance) 1.What is Quality Assurance : Quality Assurance is a deep concept covering all matters that individually or collectively influence the quality of a product. It is the complete & whole of the arrangements made with the object of ensuring that the manufactured products are of …

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OOS (Out of Specification) As PER USFDA & MHRA

OOS (Out of Specification) Definition: It is defined as those results of the in-process or Finished which has been sed products testing, which falling out specified limit or acceptance Criteria which has been specified in the official Monograph or  Product registered  Specification. OOS was found due to the following reasons: …

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Observations & Compliances response of GMP Inspections

Observations & Compliances response of GMP Inspections Observations 1: In the DM water plant, there were no records maintained for the change of air filters from the compressor to the degasser. Response: The procedure for the replacement of filters has been incorporated in the SOP for the replacement of cartridge …

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ANVISA – The Brazilian Health Surveillance Agency

The Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory. Anvisa’s role it to promote the protection of the population’s health by …

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New Product Design and Development Process

New Product Design and Development Process Objective To lay down a Procedure for New Product Design and Development Process. Scope This Standard Operating Procedure is applicable to pharmaceutical formulation plants. Responsibility Head, Clinical Research : Conducting Clinical Trials as per the Good Clinical Practices and review and compilation of data …

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Technical Directions for Drug Product Manufacturing

Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products. Objective To lay down a procedure for the Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products. Scope This Standard Operating Procedure is applicable for preparation and implementation of Technical Directions for all …

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