What is Excel Spreadsheet? Microsoft Excel is a software program. It is used to create spreadsheets, which are documents in which data is laid out in rows and columns — like a big table. Excel organizes data in columns and rows and can perform calculations on that data using formulas. Spreadsheets that are used to…
Validation master plan (VMP) is a high-level document that summarizes the manufacturer’s overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturer’s qualification and validation work programme and defines details of and timelines for the work to be performed, including a statement of the responsibilities of those implementing…
Change management is crucial in any Commissioning, Qualification, and Validation (CQV) activity within the pharmaceutical and other regulated industries for several important reasons: Robust change management helps ensure compliance, manage risks, maintain product quality, and facilitate efficient and controlled change implementation. It is an integral part of maintaining the quality, safety and efficacy of pharmaceutical…
Commissioning, Qualification, and Validation (CQV) is one of the most important phases in achieving cGMP and regulatory compliance for a pharmaceutical manufacturing facility. CQV is a systematic approach to ensuring that facilities, equipment, and processes meet the required quality and regulatory standards. Each phase serves a specific purpose in the lifecycle of the facility or…
What is Validation? As per EU GMP – It is “Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to expected results. What is Qualification? Comparison between Qualification and Validation Why Validation? What to Qualify/Validate? Validation Documentation Validation Master Plan…
The cleaning processes of multiple product use equipment in the facilities are subject to requirements for cleaning validation. The validation effort could be huge. In order to minimize the amount of validation required, a worst case approach for the validation can be used. Bracketing ProcedureThe first thing to do is to make groups and sub…
This guidance document was published by the APIC Cleaning Validation Task Force on behalf of the Active Pharmaceutical Ingredient Committee (APIC) of CEFIC for cleaning validation in active pharmaceutical ingredient manufacturing plants. Six specific areas are addressed in this Guidance document: Acceptance Criteria Companies must demonstrate during cleaning validation that the cleaning procedure routinely employed…
Cleaning validation is a crucial process in the pharmaceutical industry that involves ensuring that equipment and facilities are free of residue and contaminants that could impact product quality and safety. Over the years, different approaches and techniques have been developed and adopted for cleaning validation, each building on the successes and limitations of the previous…