FDA’s recent released Guidance for Industry on Data Integrity and Compliance with Drug CGMP Questions and Answers (CGMPs also known as current Good Manufacturing Practices), clarifies data integrity’s role for drugs and biologics as required in 21 CFR part 210 (the Manufacturing, Processing, Packing, or Holding of Drugs), 21 CFR part 211 (for Finished Pharmaceuticals), and 21 CFR part 212 (for Positron Emission Tomography (PET) Drugs). This Guidance for Industry, the Agency says, is also consistent with consistent guidance on cGMPs for active pharmaceutical ingredients with respect to data integrity. Of course, everyone knows of GMPs are minimum requirements that companies must meet in the development and execution of acceptable procedures for pharma manufacturing processes - from hygienic practices of employees and their work environments, to record keeping to how to handle returns and overages to specifications and testing of in-process and finished products. Data integrity plays a key role in all areas of GMP compliance and FDA expects data to be meaningful, taking into consideration the design, operation, and monitoring of systems and controls based on risk to patient, process, and product. In addition, FDA expects the data to be reliable, including a demonstration of integrity, validation, safety, identity, strength, quality, and purity, reproducibility and so on. ISO 45001 Training
FDA’s recent released Guidance for Industry on Data Integrity and Compliance with Drug CGMP Questions and Answers (CGMPs also known as current Good Manufacturing Practices), clarifies data integrity’s role for drugs and biologics as required in 21 CFR part 210 (the Manufacturing, Processing, Packing, or Holding of Drugs), 21 CFR part 211 (for Finished Pharmaceuticals), and 21 CFR part 212 (for Positron Emission Tomography (PET) Drugs). This Guidance for Industry, the Agency says, is also consistent with consistent guidance on cGMPs for active pharmaceutical ingredients with respect to data integrity. Of course, everyone knows of GMPs are minimum requirements that companies must meet in the development and execution of acceptable procedures for pharma manufacturing processes - from hygienic practices of employees and their work environments, to record keeping to how to handle returns and overages to specifications and testing of in-process and finished products. Data integrity plays a key role in all areas of GMP compliance and FDA expects data to be meaningful, taking into consideration the design, operation, and monitoring of systems and controls based on risk to patient, process, and product. In addition, FDA expects the data to be reliable, including a demonstration of integrity, validation, safety, identity, strength, quality, and purity, reproducibility and so on.
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