Casmara Cosmetics, S.A. USFDA warning Letter 2/21/18 For Warning Letter Click the Link –  Casmara Cosmetics, S.A. 2/12/18 For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/

Questions and answers EU GMP guide annexes: Supplementary requirements 1. How should the integrity of sterilising filters be verified? H+V June 2007 Annex 1, paragraph 85 states, ‘the integrity of the sterilised filter should be verified before use and should be confirmed immediately after use by an appropriate method such …

Questions and answers Basic requirements for active substances used as starting materials: GMP compliance for active substances 1. How can GMP compliance for active-substance manufacturers be demonstrated? H+V April 2011 Directive 2001/83/EC as amended (Directive 2001/82/EC for veterinary medicinal products) states that manufacturing-authorisation holders are obliged to use, as starting materials, only active substances that have been manufactured …

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 …

Validation of computerized systems 1. General 2. System specification 3. Functional specification 4. Security 5. Back-ups 6. Validation 7. Validation of hardware and software 7.1 Hardware 7.2 Software General Computer systems should be validated at the level appropriate for their use and application. This is of importance in production as well …

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 …

Stability Testing of New Drug Substances The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the …

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 …