FDA · Life Science & Pharma: GxP - CSV & Data Integrity
21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
In force Quality foundations · Regulation Last verified: not yet · Source last checked 3 Nov 2026
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The US rules for making finished medicines, known as drug CGMP. Section 211.68 is the part that covers computers and automated equipment.
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Lifecycle
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- Published at 43 FR 45077
In plain English
US CGMP rules for finished pharmaceuticals. Section 211.68 allows computers and automated equipment in manufacture if they are routinely checked under a written program. It requires controls so only authorised people change master records, checks on input and output, and a backup of data.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
Part 211 sets US CGMP for finished pharmaceuticals. It was published at 43 FR 45077 on 29 September 1978 and has been amended since. It is listed here because Section 211.68 is the core US rule on automatic, mechanical and electronic equipment, and FDA's data integrity guidance rests heavily on it.
Who and what it applies to
Manufacturers, processors, packers and holders of finished pharmaceuticals for human and veterinary use.
What it contains
- Section 211.68(a)
- Automatic, mechanical or electronic equipment, including computers, may be used if it performs satisfactorily. It must be routinely calibrated, inspected or checked under a written program, with written records.
- Section 211.68(b)
- Controls so that only authorised people change master production and control records or other records. Input and output must be checked for accuracy, with degree and frequency based on the system's complexity and reliability. A backup file of data must be kept, exact, complete and secure from alteration or loss. If data are eliminated by computerisation, a written record of the program and validation data must be kept.
- Section 211.68(c)
- Automated equipment can satisfy certain one-person-performs, another-checks requirements if conditions are met.
- Section 211.22
- Responsibilities of the quality control unit. FDA's AI warning letter relied on this section.
- Section 211.100
- Written procedures for production and process control. The same warning letter relied on this too.
- Rest of Part 211
- Organisation and personnel, buildings, equipment, components, production and process controls, packaging, holding and distribution, laboratory controls, records and reports, and returned and salvaged products.
Key points
- It predates modern software, yet it still applies to it.
- Only authorised people may change master records.
- Input and output must be checked, in proportion to complexity and reliability.
- Backups must be exact, complete and secure.
- Check the eCFR for the current text, as this is a live rule.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- Map your system controls to 211.68 when explaining them to FDA.
- Use the phrase on complexity and reliability to justify your level of input and output checking.
- Remember that AI-drafted CGMP documents still fall under the quality unit's responsibility.
Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| 29 Sep 1978 | Published at 43 FR 45077 | In force | Source for Published at 43 FR 45077 |
Related
How other documents connect to this one. Links explained
- Interpreted by FDA CPG 425 series· Compare with FDA CPG 425 series Unverified link
- Interpreted by FDA quality systems guide· Compare with FDA quality systems guide Unverified link
- Interpreted by FDA data integrity Q&A· Compare with FDA data integrity Q&A Unverified link
- Related to FDA AI guidance (drugs)· Compare with FDA AI guidance (drugs) Unverified link
- Related to FDA AI warning letter· Compare with FDA AI warning letter Unverified link
Official source
The official text always prevails over anything on this site.
Source: FDA. Public domain.
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