CPG Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs

Description

An increasing number of pharmaceuticals are being manufactured under the control of computer systems. The manufacturing procedures, control, instructions, specifications and precautions to be followed within such automated systems are embodied in the computer program(s) which drive the computer. Depending of the complexity of the programs, they may also contain controlling data on product formulation, batch size, yields and automated in-process sampling/testing procedures. In a manual system such procedures, instructions, specifications, precautions and other controlling data would be embodied in master production records which must be reviewed and approved before implementation and which must be maintained, as required by the current good manufacturing practice regulations (CGMP's). Such manual records are, of course, prepared in human readable form.

Scope & Applicability

• 21CFR211.186§ 211.186 Master production and control records.

  (a) To assure uniformity from batch to batch, master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated, and signed by a second person. The preparatRead full regulation →

• 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 →

• 21CFR211.100§ 211.100 Written procedures; deviations.

  (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, inRead full regulation →

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  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

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  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

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  2025-12-23

• 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

• Compounding Pharmacy/Adulterated Drug Products

  PQ Pharmacy, LLC

  2025-12-02

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