Question 1

What documents need to be in a batch record?

Accepted Answer

A complete batch manufacturing record must include: the product name, strength and batch number; references and batch numbers for all starting materials and packaging components used; dated production parameters recorded in real time at each manufacturing step; in-process control (IPC) results; analytical test results from quality control; yield and reconciliation calculations for each stage; records of any deviations with their investigation, disposition and CAPA references; and signed approvals from operators and the qualified person (QP) responsible for batch release. The specific content requirements are set out in UK GMP Chapter 4 (equivalent to EudraLex Volume 4, Chapter 4) and FDA 21 CFR Part 211.188.

Question 2

How long do pharmaceutical companies need to keep GMP records?

Accepted Answer

Under UK and EU GMP, batch records for finished products must be retained for at least one year after the product's expiry date, with a minimum of five years from the batch release date — whichever period is longer. For active pharmaceutical ingredients (APIs), the retention period is one year after the expiry of the finished product batch that used the API. FDA 21 CFR Part 211 requires a minimum of three years after the distribution date. Validation records and system qualification documents should be retained for the lifetime of the validated system or process, plus a minimum of five years thereafter.

Question 3

Does 21 CFR Part 11 apply to manufacturers based outside the United States?

Accepted Answer

Yes. FDA 21 CFR Part 11 applies to any organisation that creates, modifies, maintains, archives or retrieves electronic records that are submitted to the FDA or used to support FDA-regulated activity. A UK or EU manufacturer that exports products to the US market, participates in FDA-regulated clinical trials, or holds a US drug establishment registration is subject to Part 11 for the systems used in those activities. Practically, most sites active on both markets align their computerised system validation to both Part 11 and EU/UK GMP Annex 11 simultaneously to avoid maintaining duplicate compliance programmes.

Question 4

What is the difference between a deviation and an out-of-specification (OOS) result in GMP?

Accepted Answer

A deviation is any departure from an approved procedure, specification or standard that occurs during manufacturing or quality control operations — regardless of whether the final batch result is within specification. An out-of-specification (OOS) result is a specific category of deviation where an analytical test result falls outside the acceptance criteria in the registered specification. Every OOS result triggers a formal investigation under FDA guidance (2006 OOS Guidance) and UK/EU GMP requirements, comprising a Phase I laboratory investigation and, if required, a Phase II manufacturing investigation. Both deviations and OOS results must be documented, investigated, closed with appropriate CAPA and retained in the batch record.

Question 5

What triggers an MHRA GMP inspection, and what happens if deficiencies are found?

Accepted Answer

MHRA GMP inspections occur on a risk-based cycle — typically every two to three years for licensed sites — and may also be triggered by product recalls, serious complaints, whistleblower reports or applications for new activities. Inspection findings are classified as: Critical (direct patient risk or fundamental GMP failure, requiring immediate action and potentially licence suspension), Major (significant GMP failure without immediate patient risk, requiring a CAPA response within a defined timeframe) and Other (improvements recommended). Manufacturers with unresolved Major or Critical findings may have their manufacturing licence suspended or revoked, and MHRA publishes inspection action notices publicly. Sites subject to FDA Warning Letters may face import alert, which can effectively bar their products from the US market regardless of MHRA status.

Question 6

Do employers need to re-check workers who already have settled status?

Accepted Answer

No. The EU Settlement Scheme grants indefinite leave to remain (settled status), which creates a permanent right to work. Employers who conducted a valid check at the time of hire retain their statutory excuse indefinitely. No follow-up check is required, though many employers choose to update records for completeness.

Question 7

What should an employer do if a worker's visa is about to expire?

Accepted Answer

Set an expiry alert at least four weeks before the visa expiry date. Contact the worker to confirm they have applied for an extension, then use the ECS or share code system to verify their ongoing right to work. If the worker provides a Certificate of Application, submit an ECS request to obtain a Positive Verification Notice before the current permission expires.

Question 8

Can employers accept a passport without a visa endorsement?

Accepted Answer

Only for British or Irish passports held by nationals of those countries. A foreign national's passport without a valid visa or share code confirmation does not establish the right to work in the UK. Accepting a passport alone in this case does not create a statutory excuse.

Question 9

Is it legal to photocopy a worker's passport or BRP?

Accepted Answer

The statutory guidance recommends retaining a copy — not the original — of the document or a record of the share code check result. There is no legal bar on photocopying immigration documents for this purpose, provided copies are held securely and disposed of after the retention period. Under UK GDPR Article 5(1)(e), copies should not be retained longer than necessary.

Question 10

Does the right to work check obligation apply to self-employed contractors?

Accepted Answer

No. The civil penalty regime under IAN Act 2006 applies to employment relationships. Engaging a genuinely self-employed contractor does not trigger the right to work check duty. However, sham self-employment to avoid the obligation is itself an offence, and agencies placing workers must conduct their own checks.

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