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The Importance of Cleaning Validation in Pharmaceutical Industry

Pharmacy is closely related to healthcare. So, everything about pharmaceutical activities


must be in a clean condition. Pharmaceutical manufacturers must validate their cleaning process
to complies the cGMP (current Good Manufacturing Practices) regulations. In the
pharmaceutical industry, cleaning has a main priority to ensure the safety, quality, and purity of
the drugs. FDA (Food and Drug Administration) has published a first cleaning validation
guidelines referencing in 1991, they also published “Pharmaceutical cGMPs for the 21st Century:
A Risk-Based Approach” in 2002 and the validation was reinforced in pharmaceutical
manufacturing (Lodhi dkk., 2014).

Cleaning validation is a documented process that proves the effectiveness and consistency in
cleaning a pharmaceutical equipment (Prabu & Suriyaprakash, 2010). This process prove that the
define procedure can eliminate the API (Active Pharmaceutical Ingredient) residues from the
equipment preparation till packaging process. Its also controlled the microbial contamination at
the acceptable level. The purpose of cleaning validation is to prevent contamination or cross-
contamination in pharmaceutical dosage forms. This cross-contamination may be from previous
product batches, cleaning agent, or other extraneous material. There are some reasons why
pharmaceutical manufacturers need to validate cleaning procedures (Lodhi dkk., 2014):

1. Pharmaceutical products and API can be contaminated by other pharmaceutical products,


cleaning agent, and microbial contamination. It can lead to adulterated product which is
harmful for human.
2. Regulatory requirement in pharmaceutical product manufacture, the concern is the same-
assurance that equipment is clean and product quality and safety are maintained.
3. It is also assure from an internal control and compliance point of view the quality of
manufacturer.
4. Protect the product integrity.
5. Reuse the equipment, so it can minimize the cost production.

Cleaning validation in pharmaceutical industry is the most important and primary activities,
because its directly related to quality of the product such as drugs. The appropriate and trusted
procedures of cleaning validation can produce a safety product. Safety means contamination free,
gives the good quality and efficacy, and doesn’t cause a new health problem or side effects.
Adulterated products especially caused by microbial agent lead to resistance cases. So, its very
important for industry to has a cleaning validation procedures that appropriate for their product.
Element of cleaning validation by Lodhi dkk (2014) such as residue selection, equipment
characterization, cleaning agent selection, limits calculation, product grouping, cleaning
procedure, sampling, analytical methods, validation protocol, and validation report. Besides
health, cleaning validation also related to economic aspect. Its because, with the good
preparation and proper implementation of cleaning validation procedures, can reduce the starting
material or other substances which was use for produces the drugs, through the reduction of
production failed products or adulterated products. Reuse the equipment also can minimize the
cost production if the cleaning procedure was applied properly, so there is no contamination or
other substances left behind which can damage it.

References:

Lodhi, B., Padamwar, P. & Patel, A., 2014, Review Article: Cleaning validation for the
pharmaceuticals, biopharmaceuticals, cosmetic and neutraceuticals industries, Journal of
Innovations in Pharmaceuticals and Biological Sciences., 1 (1), 27-38.

Prabu, L.S. & Suriyaprakash, T.N.K., 2010, Cleaning Validation and its importance in
Pharmaceutical Industry, Pharma Times., 42 (7), 21-25.