QA & QC

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 …

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: …

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 …

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 …

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 …

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 …

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 …

Un-Planned Deviation – II in Pharma Details for Deviation No. ________ Department                                         :           Production Investigation start date                      :           Investigation completion date:           INVESTIGATION TEAM S.No. Name Designation Department 1. Production Head Production 2. Production Manager Production 2. EngineerTechnologist Production 4. QAOfficer Quality Assurance 5. QA Head Quality Assurance   …

Un-Planned Deviation in Pharma Investigation Report Description of Deviation: The document entry of dispensing and cleaning records is not recorded by the respective operators. Type of deviation:  Un-Planned Deviation Class of Deviation:  Minor Date of investigation:   Department:  Warehouse Date of deviation Observed:   Investigations start date:   Investigation completion date:   INVESTIGATION TEAM …

SOP LIST (Quality Assurance) S. No. SOP Title 1.        Preparation, Approval, and Control of Standard Operating Procedures 2.        Vendor Approval 3. Change Control 4. Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products. 5. Preparation, Approval and Control of Specifications and Standard Test Procedures …