Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry

Description

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Data Integrity and Compliance With Drug CGMP: Questions and Answers.’’ The purpose of the guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. (Unless otherwise noted, the term CGMP refers to CGMPs for drugs, including biologics.) The guidance has been developed in response to an increase in findings of data integrity lapses in recent inspections. FDA expects that all data be reliable and accurate. CGMP regulations and guidance allow for flexible and riskbased strategies to prevent and detect data integrity issues. Firms should implement meaningful and effectivestrategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.

Scope & Applicability

Regulatory Context

• 21CFR211.180§ 211.180 General requirements.

  (a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lRead full regulation →

• 21CFR211.25§ 211.25 Personnel qualifications.

  (a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performsRead full regulation →

• 21CFR211.192§ 211.192 Production record review.

  All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (inRead full regulation →

• 21CFR211.22§ 211.22 Responsibilities of quality control unit.

  (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no eRead full regulation →

• 21CFR212.60§ 212.60 What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?

  (a) Testing procedures. Each laboratory used to conduct testing of components, in-process materials, and finished PET drug products must have and follow written procedures for the conduct of each test and for the documentation of the results.Read full regulation →

• 21CFR211.194§ 211.194 Laboratory records.

  (a) Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows:Read full regulation →

• 21CFR211.68§ 211.68 Automatic, mechanical, and electronic equipment.

  (a) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinelyRead full regulation →

• 21CFR11.2§ 11.2 Implementation.

  (a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met.Read full regulation →

• CGMP/Finished Pharmaceuticals/Adulterated

  SV Labs Corporation

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Guangdong Renhe Guozhuang Biotechnology Co., Ltd.

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Medinatura New Mexico, Inc.

  2025-12-23

• CGMP/Positron Emission Tomography (PET) Drugs/Adulterated

  3D Imaging Drug Design and Development LLC

  2025-12-16

• CGMP/Finished Pharmaceuticals/Adulterated

  Sklar Personal Care Inc.

  2025-12-16

• CGMP/Deviations/Biologics License Application (BLA)

  Microvascular Tissue, Inc.

  2025-12-16

• CGMP/Finished Pharmaceuticals/Adulterated

  Catalent Indiana, LLC

  2025-12-11

• CGMP/Finished Pharmaceuticals/Adulterated

  DeVere Manufacturing Inc.

  2025-12-09

• CGMP/Finished Pharmaceuticals/Adulterated

  CDL Services, Inc. DBA Technichem

  2025-12-09

• CGMP/Finished Pharmaceuticals/Adulterated

  Seaway Pharma Inc.

  2025-12-09

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