Tag Archives: Vasai Virar

Questions and answers on Data integrity Data integrity Data integrity enables good decision-making by pharmaceutical manufacturers and regulatory authorities.It is a fundamental requirement of the pharmaceutical quality system described in EU GMP chapter 1, applying equally to manual (paper) and electronic systems. Promotion of a quality culture together with implementation …

Deviation Handling and Quality Risk Management Purpose The aim is to contribute to the understanding of a quality risk management approach in the handling of deviations from a practical perspective as per WHO expectations.  The intent is to support the effective and timely implementation of tools related to deviation management …

Human interventions in aseptic processing It is appropriate to focus on human interventions performed during aseptic processing because no other factor has the same potential for introducing contamination. Sterilization processes, environmental sanitization, room design, and heating and ventilation systems are all substantially less significant as sources of contamination. Personnel continuously shed microorganisms and particles to …

Non-sterile process validation as per WHO Technical Report Series, No. 937 1. Principle 2. Scope 3. General 4. Prospective validation 5. Concurrent validation 6. Retrospective validation 7. Revalidation 8. Change control Principle Process validation provides documented evidence that a process is capable of reliably and repeatedly rendering a product of the …

Analytical method validation as per WHO Technical Report Series, No. 937 Principle General Pharmacopoeial methods Non-pharmacopoeial methods Method validation Characteristics of analytical procedures Principle This appendix presents some information on the characteristics that should be considered during validation of analytical methods. Approaches other than those specified in this appendix may be followed …

Cleaning validation protocols Cleaning validation should be described in cleaning validation protocols,which should be formally approved, e.g. by the quality control or quality assurance unit. In preparing the cleaning validation protocol, the following should be considered: — disassembly of system — precleaning — cleaning agent, concentration, solution volume, water quality — time …

Stability Testing of Drug Substances and Products A. General QUESTIONS  1: What is the scope of and implementation date for the FDA stability guidance? ANSWERS 1: The FDA stability guidance covers all new ANDAs under the Federal Food, Drug, and Cosmetic Act, section 505 (j), and DMFs (Type II for drug substances …

Qualification as per WHO Technical Report Series, No. 937 Qualification should be completed before process validation is performed. The process of qualification should be a logical, systematic process and should start from the design phase of the premises, equipment, utilities and equipment. Depending on the function and operation of the equipment, utility or …

Validation as per WHO Technical Report Series, No. 937 Approaches to validation Two basic approaches to validation — First is based on evidence obtained through testing (prospective and concurrent validation), and  Second is based on the analysis of accumulated (historical) data (retrospective validation). Whenever possible, prospective validation is preferred. Retrospective validation is no …

Investigating Out-of-Specification This topic provides how to evaluate out-of specification (OOS) test results.  the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process …

Question 1. What Is Cleaning Validation? Answer:   To evaluate the capability of cleaning procedure  in removing the drug residue and microbiological bio burden on equipment within established acceptance criteria, through the validation of cleaning procedures. To establish sufficient documented evidence to assure that, cleaning procedures can repeatedly and reproducibly remove …

Stability Testing of New Drug Products ( Q1A(R2)) The design of the formal stability studies for the drug product should be based on knowledge of the behavior and properties of the drug substance, results from stability studies on the drug substance, and experience gained from clinical formulation studies. The changes on storage and …

GLOSSARY AS PER STABILITY TESTING ICH GUIDELINE (Q1A(R2)) Accelerated testing: Studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions as part of the formal stability studies. Bracketing: The design of a stability schedule such that only samples …

VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY INTRODUCTION This guideline is complementary to the parent guideline which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. Its purpose is to provide some guidance and recommendations on how to consider the various validation characteristics for each analytical procedure. In …

VALIDATION OF ANALYTICAL PROCEDURES (DEFINITIONS AND METHODOLOGY) 1. INTRODUCTION This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the EC, Japan and USA. This document does not necessarily seek to cover the testing that may be required …

GLOSSARY – Validation of Analytical Procedures 1. Analytical Procedure: The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of …

PILOT SCALE-UP AND PROCESS VALIDATION The development of product prior to the preparation of the first pilot-production batch. The development activities are listed as follows: 1. Formulation design, selection, and optimization 2. Preparation of the first pilot-laboratory batch 3. Conduct initial accelerated stability testing 4. If the formulation is deemed stable, preparation …

WHAT IS PROCESS VALIDATION? The process validation is derived from the fact that the specific exercise of process validation should never be designed to fail. Failure in carrying out the process validation assignment is often the result of incomplete or faulty understanding of the process’s capability, in other words, what …

Master Plan or Protocol for Process Capability Design and Testing Objective Process capability design and testing Types of process Batch, intermittent, continuous Typical processes Chemical, pharmaceutical, biochemical Process definition Flow diagram, in-process, finished product Definition of process output Potency, yield, physical parameters Definition of test methods Instrumentation, procedures, precision, and …

Checklist of Qualification and Control Documentation The FDA, as per existing cGMP regulations and considers process validation necessary because it makes good engineering sense. Organization and personnel – Responsibilities of the quality control unit Buildings and facilities : Plant and facility installation and qualification Maintenance and sanitation Microbial and pest control Equipment …