HACCP VALIDATION REPORT

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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 collecting and evaluating the hazards … Read more

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. Question: How many Types of … Read more

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 the quality required for their … Read more

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: Laboratory Related OOS Process Related … Read more

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 filters. A format is also … Read more

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 executing sanitary control of the … Read more

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 for DCGI permission. Head, RA … Read more

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 products manufactured at all pharmaceutical … Read more

Un-Planned Deviation -3 in Pharma

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Un-Planned Deviation Details for Deviation No.______________ Department                       :               Production Investigation starts date:             Investigation completion date: INVESTIGATION TEAM S.No. Name Designation Department 1. Production Head Production 2. Production Manager Production 2. Engineer Technologist Production 4. QA Officer Quality Assurance 5. QA Head Quality Assurance   Sr. No. Product Batch No. BMR Reference Number   … Read more

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