Biotech Quality Software

  • Date: February 18, 2011
  • Source: Admin
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Current Good Manufacturing Practice (CGMP)

21 CFR Parts 210 and 211

­         CDER CGMP Regulations and Controls Used for Manufacturing, Processing, Packing, or Holding Drugs

­         Contain the minimum CGMP for methods to be used in - and the facilities or controls to be used for - the manufacture, processing, packing, or holding of drug products to ensure that they meet regulatory requirements as to safety and strength, quality, and purity.

Electronic Record-Keeping Systems Requirements

21 CFR Part 11

Developed to set standards for systems containing electronic records and electronic signatures.

Validation of the system used within its current operating environment.

­         “Persons must still comply with all applicable predicate rule requirements for validation (e.g., 21 CFR 820.70(i)).”

­         “We recommend that you base your approach on a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety and record integrity.”

­         “For further guidance on validation of computerized systems, see FDA’s Guidance for Industry and FDA Staff CDRH “General Principles of Software Validation” and industry guidance such as the “GAMP4 Guide for Validation of Automated Systems”.



­         Widely used, internationally accepted, guideline for validation of computer systems.

­         GAMP Guide is produced by ISPE and the GAMP Forum.


Additionally, manufacturers in the Biotechnology industry need to meet regulatory requirements set by the FDA and other regulatory bodies, including the National Institutes of Health (NIH), and the Occupational Safety and Hazard Administration (OSHA).

Guidance: FDA

Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

Regulatory framework (Process Analytical Technology to encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance.

General Principles of Software Validation

General validation principles considered to be applicable to the validation of medical device software or software used to design, develop, or manufacture medical devices.

Risks of noncompliance

FDA regulatory action: The agency will consider regulatory action with respect to Part 11 when the electronic records or electronic signatures are unacceptable substitutes for paper records or handwritten signatures, and therefore, requirements of the applicable predicate regulations (e.g., CGMP and Medical Device QSR regulations) are not met. The agency issues warning letters.


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