A review on role of cleaning validation protocol in Pharmaceutical manufacturing unit

Harshavardhan K et al., Int. J. Rev. Life. Sci., 1(3), 2011, 151-158

©JK Welfare & Pharmascope Foundation | International Journal of Review in Life Sciences

151

A review on role of cleaning validation protocol in

Pharmaceutical manufacturing unit

K. Harshavardhan*1

, V.S.Thiruvengada Rajan 1

, N. Amruth Kumar 1

, S.Angala Parameswari 1,

C.Madhusudhana Chetty 2

1

Department of Pharmaceutical Analysis and Quality Assurance, 2

Department of Bio-Technology,

Annamacharya College of Pharmacy, Rajampet-516126, Andhra Pradesh, India

ABSTRACT

Cleaning validation is must in order to identify and correction of potential problems previously unsuspected which shows effect on safety, efficacy and quality of subsequent batches of drug product with in the equipment. Manu-factures and authorities set high standards for the effective and reliable cleaning of production equipment in or-der to prevent cross contamination. Regulations, tight deadlines and increasing awareness of cost necessitate effi-cient and residue free cleaning processes. Residue free cleaning is a key factor in the life cycle of any chemical pharmaceutical product from research and development in the laboratory during scale up in the pilot plant and finally at the production site. An effective cleaning process takes all the individual factors in to account and is based on precise knowledge of the product mix and cleaning chemistry which results in greater efficiency and lower costs. The benefits due to cleaning validation are compliance with federal regulations, identification and correction of potential problems, previously unsuspected which could compromise the safety and efficacy of drug products.

Keywords: Analytical testing methods; cleaning validation protocol; cleaning validation; validation. INTRODUCTION

Cleaning validation provides documented evidence that the cleaning methods employed with in a facility are effective and consistent in cleaning pharmaceutical production equipment. Validation of equipment clean-ing procedures is mainly used in pharmaceutical indus-tries to prevent cross contamination and adulteration of drug products. The important task of performing a cleaning validation is to identify and correction of po-tential problems previously unsuspected which shows effect on safety, efficacy, or quality of subsequent batches of drug product produced within the equip-ment. Cleaning validation is important like that of pro-duction process and the process validation. It is there-fore deserves the same careful attention. The main rationale for requiring clean equipment is to prevent contamination or adulterations of drug products (Gala-towitsch S 2000). Objective

Cleaning validation should be followed for prevention of interactions between active pharmaceutical ingre-dients. The cleaning of difficult to reach surface is one

of the most important consideration in equipment cleaning validation. It is necessary to validate cleaning procedure for the following reasons (Cleaning Valida-tion, 1999)

1. Customer requirement-it ensures the safety and the purity of the product.

2. Regulatory requirement in active pharmaceutical ingredient product manufacture.

3. Assurance from an internal control and compliance point of view the quality of process.

When the cleaning process is used only between batches of the same product the firm need to meet criteria of visible clean for the equipment. Residue free cleaning is a key factor in the life cycle of any chemical pharmaceutical product from research and develop-ment in the laboratory during scale up in the pilot plant and finally at the production site. An effective cleaning process takes all the individual factors in to account and is based on a precise knowledge of the product mix and cleaning chemistry (Mendenhall DW 1989). Various types of contaminants Contamination with active ingredients

Cross contamination with Active ingredients may cause potential clinically significant synergistic interactions between pharmacologically active chemicals and it causes an unintended pharmacological activity so con-tamination of one batch product with residual active

* Corresponding Author

Email: harshan17@http://www.360docs.net/doc/info-0937b04e5901020206409c64.html Contact: +91-9966981423 Received on: 04.07.2011 Revised on: 25.08.2011 Accepted on: 04.09.2011

http://www.360docs.net/doc/info-0937b04e5901020206409c64.html

ISSN: 2231-2935 Review Article

A review on role of cleaning validation protocol in Pharmaceutical manufacturing unit的相关文档搜索

相关文档
11-VTI-Developing an Effective Cleaning Validation Program May 12th 2010 Reev[1]-cn. 1《2010制药工程
选定的限度 规程培训-清洗、取样、测试/分析 – 三个清洗挑战-最差状况清洗前设备放置时间 – 标准-视觉清洗以及残留物限度 57 Cleaning Validation Documents (...
Methods for Detecting Residues of Cleaning Agents During Cleaning Validation
Methods for Detecting Residues of Cleaning Agents During Cleaning Validation_能源/化工_工程科技_专业资料。 今日推荐 88份文档 ...
A Review on Cleaning Validation in Pharmaceutical Industry
A Review on Cleaning Validation in Pharmaceutical Industry_能源/化工_工程科技_专业资料。今日推荐 78份文档 笑翻神图 爆笑图片汇集 搞笑图片乐翻人 cs3简单...
CLEANING VALIDATION PROTOCOL模板
CLEANING VALIDATION PROTOCOL模板_经管营销_专业资料。GMP Cleaning Validation ... Cleaning Validation Pr... 41页 1下载券 A review on role of cl... ...
Cleaning Validation in Pharmaceutical Industry
Cleaning Validation in Pharmaceutical Industry_医药卫生_专业资料。Clean ...The control of cross contamination plays a very important role in maintaining...
cleaning-validation-protocol-for-sample
Cleaning Validation Protocol for Sample Container Learn how to validate the cleaning procedure of sample container using spectrophotometer. 1. PURPOSE: This ...
cleaning_validation_presentation
Guidance on aspects of cleaning validation in active pharmaceutical ingredient ...Allowable acceptance limit > LOQ Cleaning Validation Protocol ? Objective ? ...
CLEANING VALIDATION PROTOCOL
CLEANING VALIDATION PROTOCOLCLEANING VALIDATION PROTOCOL隐藏>> CLEANING ...1.5 Teams and Responsibilities The roles and responsibilities for the review ...
Cleaning Validation of Multiple Equipments in Active Pharmaceutical Ingredients Manufacturing Plant
Cleaning Validation of Multiple Equipments in Active Pharmaceutical Ingredients Manufacturing Plant_能源/化工_工程科技_专业资料。今日推荐 ...
整理后复制_Validation02_Cleaning Validation
Module 1, Part 2: Cleaning validation Slide 7 of 25 ? WHO – EDM Jan 02 Validation Cleaning validation protocol (2) Should include: ? Interval ...