Audit and Guideline

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 …

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 …

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 …

WATER PURIFICATION -VALIDATION AND QUALIFICATION Establishing reliability of pharmaceutical water purification, storage, and distribution systems requires demonstrating control of the process through an appropriate period of monitoring and observation. Finished water is typically continuously produced and used, while product and process attributes may only be periodically assessed. The quality of bulk …

ANALYTICAL INSTRUMENT QUALIFICATION A large variety of laboratory equipment, instruments, and computerized analytical systems  are used in the pharmaceutical industry to acquire data to help ensure that products are suitable for their intended use. An analyst’s objective is to consistently obtain reliable and valid data suitable for the intended purpose. Depending on the …

Analytical Instrument Categories Users are  establishing the level of qualification needed for an instrument. On the basis of the level needed, it is to categorize instruments into three groups: A, B, and C, as  for detail defined below. Examples of instruments in each group are provided. Note that the list of instruments …

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USFDA WARNING LETTER 2016 (Finished Pharmaceuticals) in Pharma Noven Pharmaceuticals, Inc. 8/5/16 Huzhou Aupower Sanitary Commodity 8/10/16 Frontida BioPharm Inc 8/15/16 College Pharmacy Incorporated 8/15/16 Ajes Pharmaceuticals LLC 9/9/16 Mappel Industria de Embalagens S.A. 9/12/16 Cheng Fong Chemical Co., Ltd. 9/15/16 Yangzhou Hengyuan Daily Chemical Plastic Co Ltd 9/26/16 Laboratoire …

USFDA WARNING LETTER 2014 (Finished Pharmaceuticals) in Pharma Usv Limited 2/6/14 SmithKline Beecham (Cork) Ltd. 3/18/14 Sun Pharmaceutical Industries Limited – Karkhadi 5/7/14 Apotex Pharmachem India Pvt Ltd. 6/16/14 M.D. Science Lab 7/15/14 Zions Rx Formulations Services LLC dba Rx Formuations Serv. 8/15/14 Wells Pharmacy Network LLC 11/10/14 Pharmagen Laboratories, …

USFDA WARNING LETTER 2014 (API) in Pharma Novacyl Wuxi Pharmaceutical Co., Ltd. 12/19/14 Sharp Global Limited 10/15/14 CBSCHEM LIMITED 1/31/14   Pharma More Jobs and post Please click here  

USFDA WARNING LETTER 2015 (API) in Pharma Cadila Pharmaceuticals Limited 2/25/15 Sandoz Private Limited 10/22/15 Dr. Reddy’s Laboratories Limited 11/5/15 Zhejiang Hisun Pharmaceutical Co., Ltd. 12/31/15 Cadila Healthcare Limited 12/23/15 Unimark Remedies Ltd. 9/28/15 Sipra Labs Limited 7/23/15 Yunnan Hande Bio-Tech. Co. Ltd. 4/6/15 MyNicNaxs, Inc. 2/20/15   Pharma More …