Tag: india

Analytical method validation as per WHO Technical Report Series, No. 937

February 8, 2018February 2, 2023 Pharmaceutical Guidanace

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 and may be acceptable. Manufacturers should…

Audit and Guideline

Cleaning validation protocols and reports as per WHO Technical Report Series, No. 937

February 8, 2018February 2, 2023 Pharmaceutical Guidanace

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 and temperature — fl ow…

Audit and Guideline

Qualification as per WHO Technical Report Series, No. 937

February 1, 2018February 2, 2023 Pharmaceutical Guidanace

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 system, only installation qualification (IQ)…

Audit and Guideline

Validation as per WHO Technical Report Series, No. 937

February 1, 2018February 2, 2023 Pharmaceutical Guidanace

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 longer Used Nowadays. Both prospective…

Audit and Guideline

Investigating Out-of-Specification (OOS) in Pharmaceutical Production

January 29, 2018February 2, 2023 Pharmaceutical Guidanace

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 laboratory tests that are outside…

Audit and Guideline

Question and Answer on Cleaning validation in Pharmaceutical Industry

January 27, 2018March 8, 2023 Pharmaceutical Guidanace

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 residue of the subjected product…

Quality Assurance

Stability Testing of New Drug Products ( Q1A(R2))

January 27, 2018February 2, 2023 Pharmaceutical Guidanace

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 the rationale for the selection…

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GLOSSARY AS PER STABILITY TESTING ICH GUIDELINE (Q1A(R2))

January 26, 2018February 2, 2023 Pharmaceutical Guidanace

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 on the extremes of certain design…

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Stability Testing of New Drug Substances (ICH Q1A(R2))

January 25, 2018February 2, 2023 Pharmaceutical Guidanace

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 drug substance or a shelf life…

Audit and Guideline

VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY

January 22, 2018February 2, 2023 Pharmaceutical Guidanace

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 some cases (for example,demonstration of…

Audit and Guideline

VALIDATION OF ANALYTICAL PROCEDURES (DEFINITIONS AND METHODOLOGY)

January 21, 2018February 2, 2023 Pharmaceutical Guidanace

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 for registration in, or export…

Audit and Guideline

GLOSSARY – Validation of Analytical Procedures

January 21, 2018February 2, 2023 Pharmaceutical Guidanace

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 the apparatus, generation of the calibration…

Audit and Guideline

VALIDATION AND QUALIFICATION OF WATER PURIFICATION, STORAGE, AND DISTRIBUTION SYSTEMS AS PER USP

January 21, 2018January 30, 2024 Pharmaceutical Guidanace

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 finished water cannot be established by…

Audit and Guideline

ANALYTICAL INSTRUMENT QUALIFICATION

January 21, 2018January 27, 2024 Pharmaceutical Guidanace

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 applications, users validate their procedures,…

Audit and Guideline

Analytical Instrument Categories

January 21, 2018February 2, 2023 Pharmaceutical Guidanace

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 provided here is for illustration…

Audit and Guideline

Code to Code Transfer of Materials and Additional Testing of Materials / Products

November 4, 2017March 8, 2023 Pharmaceutical Guidanace

Code to Code Transfer of Materials and Additional Testing of Materials / Products Objective (procedure) To lay down a procedure for code transfer of the same material from one code to another and to carry out additional testing of APIs, Excipients, and Drug Products to comply with other specifications or Pharmacopoeia. Scope This standard operating…

Quality Assurance

SOP ON PROCEDURE FOR IN-HOUSE & OUTSIDE PARTY CALIBRATION

September 20, 2017November 20, 2024 Pharmaceutical Guidanace

PROCEDURE FOR IN-HOUSE & OUTSIDE PARTY CALIBRATION Calibration defines measurement parameters such as range, accuracy, and precision of an instrument. It is one of the major parts of pharmaceutical manufacturing standards and quality assurance.

Quality Assurance

SOP on In-process sampling of semi-finished product

September 16, 2017March 8, 2023 Pharmaceutical Guidanace

SOP on In-process sampling of semi-finished product Objective: To lay down the procedure for in-process sampling of semi finished drug product. Scope: This procedure is applicable to the in-process sampling of semi-finished drug product in formulation plant of Pharmaceutical company. Responsibility: IPQA personnel are responsible for collecting in-process semi finished product samples. Production personnel are…

Quality Assurance

SOP on execution of exhibit batches

September 14, 2017March 8, 2023 Pharmaceutical Guidanace

SOP on the execution of exhibit batches Objective To lay down a procedure for the execution of exhibit batches. Scope This SOP is applicable for the execution of exhibit batches to the formulation plant of a Pharmaceutical company. Responsibility Officer/above of the production and quality assurance department shall be responsible. Accountability The Head of the…

Quality Assurance

SOP on withdrawal, storage, observation & destruction of control/retention sample

September 7, 2017March 8, 2023 Pharmaceutical Guidanace

SOP on withdrawal, storage, observation & destruction of control/retention sample Objective: To lay down the procedure for withdrawal, storage, observation & destruction of control/retention sample from production (Oral & Injectable), Q.C. (RM Retention) . Scope: This SOP is applicable for the withdrawal, storage, observation & destruction of control samples from production (Oral & Injectable), and…

Quality Assurance

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