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

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

K. Harshavardhan*, V.S.Thiruvengada Rajan, N. Amruth Kumar, S.Angala Parameswari,

2

C.Madhusudhana Chetty

1

2

1

1

1

1

Department of Pharmaceutical Analysis and Quality Assurance, 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

* 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

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

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