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Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA). The concept aims at understanding the ...
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
Advanced product quality planning (APQP) is a framework of procedures and techniques used to develop products in industry, particularly in the automotive industry. It differs from Six Sigma in that the goal of Six Sigma is to reduce variation, but has similarities to Design for Six Sigma (DFSS). According to the Automotive Industry Action Group ...
Description. Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.
Good automated manufacturing practice. Good automated manufacturing practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. [1] More specifically, the ISPE's guide The Good ...
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [1] The purpose of process validation is to ensure ...
Production Part Approval Process (PPAP) is used in the Aerospace or automotive supply chain for establishing confidence in suppliers and their production processes. Actual measurements are taken from the parts produced and are used to complete the various test sheets of PPAP. "All customer engineering design record and specification ...
The Pressure Equipment Directive (PED) 2014/68/EU (formerly 97/23/EC) [1] of the EU sets out the standards for the design and fabrication of pressure equipment ("pressure equipment" means steam boilers, pressure vessels, piping, safety valves and other components and assemblies subject to pressure loading) generally over one liter in volume and having a maximum pressure more than 0.5 bar gauge.