1What a planned deviation is.
ICH Q7 defines a deviation as a “departure from an approved instruction or established standard”.¹ A planned deviation is one decided before the work starts: the company knows that a procedure, instruction or specification will not be followed as written, and approves the departure in advance instead of discovering it afterwards.
The term does not appear in 21 CFR 211, ICH Q7 or ICH Q10.²¹³ EMA uses it in its questions and answers on EU GMP Annex 16, to place planned deviations outside the route a Qualified Person has for unexpected ones.⁴ WHO’s GMP text, in section 9.14, asks the authorised person releasing a batch to make sure that “any planned changes or deviations in manufacturing or QC have been notified in accordance with a well-defined reporting system before any product is released”, and notes that such changes “may need notification to, and approval by, the medicines regulatory authority”.⁵
Calling a departure a planned deviation does not take it out of change control. ICH Q10 says that “from a pharmaceutical quality system standpoint, all changes should be evaluated by a company’s change management system”.³
2What the rules ask of any deviation.
Planned or not, a deviation is recorded, justified and authorised.
| Source | Requirement |
|---|---|
| 21 CFR 211.100(b) | Written production and process control procedures are followed and documented at the time of performance, and “any deviation from the written procedures shall be recorded and justified”.² |
| 21 CFR 211.160(a) | The same applies to laboratory controls: any deviation from written specifications, standards, sampling plans or test procedures is recorded and justified.⁶ |
| ICH Q7, 2.16 | Any deviation from established procedures is documented and explained. Critical deviations are investigated, and the investigation and its conclusions documented.¹ |
| EU GMP Chapter 4, 4.20(h) | The batch processing record carries “signed authorisation for any deviation from the Manufacturing Formula and Processing Instructions”.⁷ |
| WHO TRS 986 Annex 2, 16.3 | Deviation from instructions or procedures “should be avoided as far as possible”. Where one occurs, it follows an approved procedure and is approved in writing by a designated person, with QC involved when appropriate.⁵ |
A company that allows planned deviations therefore needs a procedure for them: who may propose one, how its effect is assessed, who approves it and how it is recorded before the work runs.
3When the departure is a change.
ICH Q10 defines change management as “a systematic approach to proposing, evaluating, approving, implementing and reviewing changes”. Each proposed change is evaluated with quality risk management, with effort “commensurate with the level of risk”, assessed against the marketing authorisation to decide whether the regulatory filing must change, and evaluated after implementation to confirm it met its objectives without harming product quality.³ EU GMP Chapter 1 asks for “the prospective evaluation of planned changes and their approval prior to implementation taking into account regulatory notification and approval where required”.⁸ ICH Q7 asks for a formal change control system “to evaluate all changes that may affect the production and control” of an intermediate or API, with the quality unit approving GMP-relevant changes, every affected document revised and the first batches made under the change evaluated.¹
In the US, procedures “including any changes” are drafted, reviewed and approved by the appropriate organisational units and reviewed and approved by the quality control unit.² FDA’s quality systems guidance adds that certain major changes, such as those that alter specifications, a critical product attribute or bioavailability, require regulatory filings and prior approval.⁹
In the EU the line is the marketing authorisation. Annex 16 lets a Qualified Person consider certifying a batch after an “unexpected deviation” from the marketing authorisation or GMP, provided registered specifications are met, the deviation is investigated and its root cause corrected, and its impact is assessed with quality risk management as negligible.¹⁰ EMA says that “planned deviations” are outside that provision and that the marketing authorisation holder should apply for a variation if one is needed. It adds that, following discovery, repeated deviations from the manufacturing process or analytical control methods “should be considered changes”, with variations to the affected marketing authorisations submitted.⁴
4Deviation record or change control.
| Situation | Where it belongs |
|---|---|
| A departure found during or after the work | A deviation, thoroughly investigated where it is unexplained or critical.¹¹¹ |
| A one-off departure from a procedure, decided in advance, that leaves registered details unchanged | A deviation approved in writing before the work, then recorded and justified.²⁵ |
| The same departure needed again | A change, evaluated and approved through change control.³⁴ |
| A planned departure from the marketing authorisation (EU) | Change control and, where needed, a variation. Annex 16 section 3.1 does not cover it.⁴ |
| A change to a specification, a critical product attribute or bioavailability (US) | Change control, with a regulatory filing and prior approval where the regulations require them.⁹ |
5How to run a planned deviation.
If your procedure allows them, give each planned deviation the same prospective evaluation EU GMP and ICH Q10 expect of a change, scaled to its risk, before the work starts.⁸³ Then:
- approve it in writing, by the designated person, with quality involved, before the work runs;⁵
- record the signed authorisation on the batch record;⁷
- make it known to the Qualified Person certifying the batch, who takes into account any deviation that could affect compliance with GMP or the marketing authorisation;¹⁰
- include it in the product quality review, which in the EU covers “all significant deviations or non-conformances” and for APIs covers critical deviations;⁸¹
- watch for repeats, which EMA treats as changes.⁴
6How it runs in Seal.
In Seal a deviation and a change control are separate, linked records. The deviation workflow links each event to the batch, sample and procedure version behind it, and keeps containment, competing explanations, the impact assessment and the disposition as records of their own; an action that is temporary keeps its expiry. Change control is configured by change type, from a major change with cross-functional review to a minor change with a proportionate path and an authorised urgent-change path with recorded scope, limits and follow-up, so urgency does not become an unrecorded bypass. A corrective action that changes how the work runs goes through change control and is verified before release, and the next batch runs the released version.
References
- 1ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, ICH, 10 November 2000. https:/
/ database. ich. org/ sites/ default/ files/ Q7%20Guideline. pdf (read 6 November 2026) - 221 CFR 211.100, Written procedures; deviations, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- F/ section- 211. 100 (read 6 November 2026) - 3ICH Q10, Pharmaceutical Quality System, ICH, 4 June 2008. https:/
/ database. ich. org/ sites/ default/ files/ Q10%20Guideline. pdf (read 6 November 2026) - 4Guidance on good manufacturing practice and good distribution practice: Questions and answers, EU GMP guide annexes: Annex 16, question 3, European Medicines Agency. https:/
/ www. ema. europa. eu/ en/ human- regulatory- overview/ research- development/ compliance- research- development/ good- manufacturing- practice/ guidance- good- manufacturing- practice- good- distribution- practice- questions- answers (read 6 November 2026) - 5WHO good manufacturing practices for pharmaceutical products: main principles, WHO Technical Report Series No. 986, Annex 2, World Health Organization, 2014. https:/
/ cdn. who. int/ media/ docs/ default- source/ medicines/ norms- and- standards/ guidelines/ inspections/ trs986annex2. pdf (read 6 November 2026) - 621 CFR 211.160, Laboratory controls: general requirements, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- I/ section- 211. 160 (read 6 November 2026) - 7EudraLex Volume 4, Chapter 4: Documentation, European Commission, January 2011. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ chapter4_ 01- 2011_ en_ 0. pdf (read 6 November 2026) - 8EudraLex Volume 4, Chapter 1: Pharmaceutical Quality System, European Commission, in operation since 31 January 2013. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ vol4- chap1_ 2013- 01_ en_ 0. pdf (read 6 November 2026) - 9Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations, FDA, September 2006. https:/
/ www. fda. gov/ media/ 71023/ download (read 6 November 2026) - 10EudraLex Volume 4, Annex 16: Certification by a Qualified Person and Batch Release, European Commission, 12 October 2015, in operation since 15 April 2016. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ v4_ an16_ 201510_ en_ 0. pdf (read 6 November 2026) - 1121 CFR 211.192, Production record review, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- J/ section- 211. 192 (read 6 November 2026)
AQuestions and answers
Does FDA accept planned deviations?
FDA’s CGMP regulations don’t use the term. They require any deviation from written procedures to be recorded and justified, and any change to those procedures to be reviewed and approved by the quality control unit. A departure that is really a change to the procedure belongs in change control, and some changes need a regulatory filing and FDA approval before they are made.
Can a Qualified Person certify a batch made under a planned deviation?
Not under Annex 16’s provision for unexpected deviations. EMA says planned deviations fall outside section 3.1, and that the marketing authorisation holder should apply for a variation if one is needed. Whatever the route, the QP certifying the batch has to be aware of any deviation that could affect compliance with GMP or the marketing authorisation.
How many times can the same planned deviation be raised?
No regulation sets a number. EMA says that once a deviation has been discovered, repeated deviations from the manufacturing process or analytical methods should be considered changes, with variations to the marketing authorisation submitted, and ICH Q10 expects every change to go through the change management system. If the same departure keeps being needed, the need is permanent and belongs in change control.
Who approves a planned deviation?
Your procedure names the roles. WHO’s GMP text asks for a deviation to be approved in writing by a designated person, with QC involved when appropriate, and in the US the quality control unit approves production procedures and any changes to them. Approval comes before the work, since the point is to assess the departure before it happens.
Should planned deviations appear in the product quality review?
Yes, where they are significant. EU GMP asks the product quality review to cover all significant deviations or non-conformances and their investigations, and ICH Q7 asks API reviews to cover critical deviations. Reviewing planned deviations there also shows whether one keeps recurring.