Cleaning validating individual pieces of equipment
They should represent different departments depending on the validation work to be performed.(Periodic revalidation or periodic requalification may be substituted, where appropriate, with periodic evaluation of data and information to establish whether requalification or revalidation is required.)4.2.7 Validation should be done over a period of time, e.g.at least three consecutive batches (full production scale) should be validated, to demonstrate consistency.I still remember the first time I met Ken when I was a young man eager to learn and attending a meeting in Washington in 1981 where FDA top officials were "laying it on the line" in terms of giving their expectations for computer validation.In those days, it was very clear who were the regulators and who were the regulated.The basic principles of quality assurance have as their goal the production of products that are fit for their intended use.• Each critical step of the manufacturing process must be validated.Other steps in the process must be under control to maximize the probability that the finished product consistently and predictably meets all quality and design specifications.Sign-up for the free email updates for your daily dose of pharmaceutical tips.
The defined process, using the materials and equipment specified, should be shown to result in the consistent yield of a product of the required quality.4.2.10 Manufacturers should identify what validation work is needed to prove that critical aspects of their operations are appropriately controlled.Validation is an essential part of good manufacturing practices (GMP).It is, therefore, an element of the quality assurance programme associated with a particular product or process.For example, installation of a new centrifugal pump to replace an older model would not necessarily require revalidation.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.
In addition to the main part, appendices on validation2.1 These guidelines focus mainly on the overall concept of validation and are intended as a basic guide for use by GMP inspectors and manufacturers.