Validation policy
VALIDATION POLICY
Definition
"A Validation Policy a formal document presenting a company's approach to providing a high level of assurance that its recognised processes consistently result in products which meet their predetermined specifications"
The Validation Policy demonstrates a commitment to validation and conveys the perfect message at the start of any inspection. A clear, carefully documented policy is one of a company's most important compliance documents.
The policy documents the approach to be adopted in the compilation of validation packages supporting systems and processes that may impact on the final quality of regulated drug products.
The Validation Policy is important and should fit within the established systems and company culture.
C&M SCIENTIFIC can provide qualification protocols for a wide range of instruments to IQ ,OQ and PQ level.
Key features of the services and protocols include:
Manufacturer and model specific protocols that can be tailored to include individual needs
Document control analogous to industry and contract laboratory GMP regulations
Pre-Approval section for protocol to be completed prior to execution
Performer/Reviewer credentials and signature on each page,
Identification of the equipment to be qualified
A listing of traceable materials required to complete qualification to provide fully traceable results
The detailed procedure of how the qualification is completed,
Final Approval section to be completed following execution
The contact for validation services in C&M SCIENTIFIC LTD is: Alistair Bamford
Validation is an extremely diverse and complex area of regulatory concern, impacting all areas of pharmaceutical and medical device manufacturing, biological research and clinical testing.
Validation has become one of the most important areas of regulatory compliance for the science laboratory, particularly in the pharmaceutical industry and international regulatory agencies, led by the United States Food and Drug Administration, (FDA) now require laboratories to show validation for both methods and analytical equipment.
Within the validation programme lies the whole area of qualification testing which is carried out at predefined intervals and sets out to show that the equipment has been installed and operates or performs to the manufacturer's requirements or specifications and is suitable for its intended use.
The following somewhat simplistic schematic of the qualification programme shows the relationship between the stages of qualification testing and validated use.
The first stage of the qualification testing is known as pre-purchase qualification, commonly called a User Requirement Specification (URS), this document lays down the requirements for intended use including application and environmental requirements. This is a valuable document which allows comparison between vendors, and clearly specifies in advance all critical aspects require of the unit PRIOR to purchase.
The post-purchase element of qualification testing deals with the concepts of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to provide evidence of testing of the system through installation and operation to appropriateness for intended use.
Installation Qualification (IQ), verifies that the equipment is installed according to the manufacturer's recommendations. It covers such areas as operating conditions, physical connections, and system configuration.
Operational Qualification (OQ), is carried out to ensure that the equipment operates as it was intended to do by the manufacturer using pre-defined acceptance criteria which are derived from the operational specifications. This normally excludes any customer defined loading
The final area of qualification testing is the Performance Qualification (PQ), also termed suitability for use. It generally takes the form of predetermined loads and configurations, along with some dynamic test situations.
It is considered best practise to summarise the outcomes of the IQ, OQ PQ in a single report.