PIC/S updates guideline on process qualification and validation studies
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has released a revised guide for inspectors and the pharmaceutical industry outlining the general principles of qualification and validation studies in pharmaceutical manufacturing facilities.
Its purpose is to guide inspectors and the pharmaceutical industry by promoting medicinal quality assurance through a validation program compliant with good manufacturing practice (GMP).
The guideline will take effect on 1 October and replaces a previous guideline that was implemented in September 2007. It also supersedes four other PIC/S documents: the PIC/S Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, and Cleaning Validations.
The recommendations were crafted by a working group from PIC/S, chaired by Norman Gray from the UK's Medicines & Healthcare Products Regulatory Agency (MHRA), Kevin O’Donnell from Ireland’s Health Products Regulatory Authority (HPRA), and Rebecca Dowd from the US Food and Drug Administration (FDA).
PIC/S emphasized that this document addresses specific areas in pharmaceutical manufacturing that have been identified by PIC/S inspectorates as needing further guidance beyond what is provided in the PIC/S GMP Guide Annex 15. Annex 15 outlines the principles of qualification and validation that apply to the facilities, equipment, utilities, and processes used in the manufacture of medicinal products.
The document covers qualification and validation principles, quality risk management (QRM) principles in qualification and validation, a validation master plan, prequalification and qualification stages for facilities, supporting utilities, equipment and systems, process validation, and cleaning validation.
The guidance states that “the aim of qualification studies is to provide documentary evidence that facilities, supporting utilities, equipment and systems are suitable for their intended use. The validation programme aims to demonstrate that control strategies are robust and that manufacturing processes are reproducible to ensure that any potential sources of variability are minimised.”
Changes from the 2007 version include removing the requirement for three validation batches to show that a product is being manufactured in a controlled manner.
The update states that “the number of validation batch replicates should be based on sound science and the manufacturer’s overall level of product and process understanding and demonstrable control. A risk assessment of the potential variability in the product is useful. Increased variability or risk should normally result in an increased number of batches and further intensification in sampling during the validation study to support the proposed commercial process and a basis for future sampling plans.”
The revision also adds a section on visual inspections, introduces a section on analytical methods, and includes a section on cleaning validation.
The document does not address the validation of computer systems, as this topic is already covered in the PIC/S GMP Guide Annex 11. Additionally, it does not discuss the validation of analytical test methods, which is also addressed in existing published guidance.
