Those who work in facilities for which cleaning is a must have to ensure that they comply with the required cleaning validation regulatory compliance guidelines set out by the regulatory authorities such as the FDA, WHO, PIC/S and EU.

The basis for the establishment of these regulatory guidelines is that these cleaning procedures need to demonstrate verifiable standards of hygiene and safety. Expectedly, the regulations relating to cleaning validation principles are extremely stringent, detailed and demanding.

A myriad of approaches and requirements

Regulatory guidelines for cleaning validation need to be based on sound scientific principles and practices. Cleaning validation has to be risk based and reasonable, into which informed decision-making and proper activity planning should have gone in.

In the process of complying with cleaning validation regulatory guidelines and scientific principles, cleaning has to include highly precise concepts such as:

Determining the residues to be targeted

Selecting the right analytical and sampling methods

Determining the appropriate limits in various pharmaceutical and biotechnology processes

Establishing scientific rationales acceptable to regulatory inspectors

Cleaning validation has to be process oriented

All these have to lead to the development of a general policy, i.e. a “Cleaning Validation Master Plan”, into which the appropriate documentation for each study needs to be performed. Those in charge of the cleaning validation program have to also be aware of the requirements for maintenance of the validated status. In addition, regulatory requirements and the latest industry practices have to also be inculcated.

Do all these sound complex? They need not be for participants of a detailed learning session on this topic by GlobalCompliancePanel, a well-known provider of regulatory compliance trainings.

Attendance at this two-day, comprehensive seminar, for which all that you need to do is log on to http://goo.gl/ZNVkyf , will clear all the doubts regarding cleaning validation and all its elements.

The Director of this seminar is Joy McElroy, Principal Consultant at Maynard Consulting Company. With 12 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification.