Самоинспекция должна проводиться с целью проверки выполнения предприятием требований настоящих Правил и предложения необходимых корректирующих действий.
9.1. Вопросы, касающиеся персонала, а также помещения, оборудование, документацию, технологический процесс, контроль качества, реализацию лекарственных препаратов, мероприятия по работе с претензиями и в отношении отзывов и деятельность по проведению самоинспекций следует регулярно анализировать в соответствии с заранее утвержденной программой по определенному графику для проверки их соответствия принципам обеспечения качества.
9.2. Самоинспекция должна проводиться независимо и тщательно специально назначенным квалифицированным(ыми) лицом (лицами), состоящим(ими) в штате предприятия. При необходимости может быть проведен независимый аудит экспертами сторонних организаций.
9.3. Результаты самоинспекций должны быть оформлены документально.
Отчеты должны содержать в себе все наблюдения, сделанные в ходе проверки, и, где применимо, предложения по корректирующим действиям. Действия, предпринимаемые по результатам проведенных самоинспекций, также следует оформлять документально.
Why do inspectors already look at an organisation’s QMS and QRM programmes during inspections? Looking at how companies react when things go wrong or are changing and are under pressure is a major diagnostic indicator of the robustness of the scientific and organisational integrity of a company’s operations
– Do they investigate to improve knowledge or simply build arguments for release of product
– Quality of investigations- appropriateness of depth of investigation
– Reactive rather than proactive usage of knowledge
– Quality is everyone’s responsibility – Is this true when things go wrong?
– Is the company a learning organisation? And where is it on the learning curve?
Critical Deficiency – an observation that has produced, or may result in a significant risk of producing a product which is
harmful to the user.
Major Deficiency – a non-critical deficiency which either:
- has produced or may produce a product which does not comply with its prequalification application (including variations); and/or
- indicates a major deviation from the GMP guide; and/or
-indicates a failure to carry out satisfactory procedures for release of batches; and/or
-indicates a failure of the person responsible for QA/QC to fulfill his/her duties; and/or
-consists of several other deficiencies, none of which on its own may be major, but which may together represent a major deficiency and should be explained and reported as such.
- An observation that cannot be classified as either critical or major, but indicates a departure from good manufacturing practice.
- A deficiency may be “other” either because it is judged as minor, or because there is insufficient information to classify it as major or critical.
EMEA Classification of observations
Critical GMP observations
- failure occurs when a practice could give rise to a product which could or would be harmful to the patient or animal, or which has produced a harmful product.
- a combination of major deficiencies, which
indicates a serious system failure, may also be classified as a critical deficiency.
A deficiency may be classified as major for the following reasons:
- A non-critical deficiency which has produced or may produce a product, which does not comply with its marketing authorisation; or
- A non-critical deficiency which indicates a major deviation from EU GMP; or (within EU) A non-critical deficiency which indicates a major deviation from the terms of
the manufacturing authorisation; or
- A non-critical deficiency which indicates a failure to carry out satisfactory procedures for
release of batches or (within EU) a failure of the Qualified Person to fulfill his legal duties;
- A combination of several “other” deficiencies, none of which on their own may be major,
but which may together represent a major deficiency and should be explained and reported as such.
Deficiencies which are classified as “other” represent deficiencies which cannot be classified as critical or major, possibly because of lack of information, but which nevertheless indicate departures from GMP. They are not necessarily of a minor nature and are essentially unclassified.
- A deficiency which has produced or significantly risks producing a product which is harmful to humans or veterinary patients or which could result in a harmful residue in a food-producing animal.
- Any departure from good distribution practice that results in a significant risk to patients. This includes an activity which increases the risk of counterfeit medicines reaching patients.
Major deficiency a non-critical deficiency which:
- has or may produce a product that doesn’t comply with its marketing authorisation
- indicates a major deviation from GMP or GDP or from the terms of the manufacturer licence or wholesale licence
- indicates a failure to carry out satisfactory batch release procedures or (within EU) a failure of the Qualified Person or Responsible Person to fulfil their legal duties
- a combination of several ‘other’ deficiencies which on their own may not be major but together may represent a major deficiency and should be explained and reported as such
A deficiency which cannot be classified as either critical or major or there is not enough information to classify it as critical or major but which indicates a departure from good manufacturing and distribution practice.
Critical observation (Risk 1) : Observation describing a situation that is likely to result in a non-compliant product or a situation that may result in an immediate or latent health risk and any observation that involves fraud, misrepresentation or falsification of products or data. Major observation (Risk 2) : Observation that may result in the production of a drug not consistently meeting its marketing authorization. Certain Risk 2 observations may be upgraded to Risk 1 Other observation (Risk 3) : Observation that is neither critical nor major but is a departure from the GMP.