Categorisation of Deficiencies

TGA CRITICAL DEFICIENCY A deficiency that has produced, or may result in a significant risk of producing a product that is harmful to the user. Critical deficiencies must be rectified before licence or certification is granted. (Not applicable to MAJOR DEFICIENCY Medical Device audits.) Is a non-critical deficiency /nonconformity that: has produced or may produce a product which does not comply with its marketing authorisation (in some circumstances this could be critical); and/or indicates a major deviation from the Code of GMP or QMS standard; and/or indicates a major deviation from the terms of the manufacturing licence, GMP approval (overseas manufacturers), or Conformity Assessment Certificate; and/or indicates a failure to carry out

PIC/S, TAIWAN A deficiency which has produced, or leads to a significant risk of producing either a product which is harmful to the human or veterinary patient or a product which could result in a harmful residue in a food producing animal. A non-critical deficiency: which has produced or may produce a product, which does not comply with its marketing authorisation; or which indicates a major deviation from PIC/S Good Manufacturing Practice; or (within PIC/S) which indicates a major deviation from the terms of the manufacturing authorisation; or which indicates a failure to carry out satisfactory procedures for release of batches or (within

MHRA, EMA, A deficiency which has produced, or leads to a significant risk of producing either a product which is harmful to the human or veterinary patient or a product which could result in a harmful residue in a food producing animal. A non-critical deficiency: That has produced or may produce a product, which does not comply with its marketing authorisation or which indicates a major deviation from EU Good Manufacturing Practice or (within EU) which indicates a major deviation from the terms of the manufacturing authorisation or which indicates a failure to carry out satisfactory procedures for release of batches or (within EU) a failure of the Qualified

WHO Geneva A deficiency which had produced, or led to a significant risk of producing, either a product which was harmful to the human patient or a product which could result in a harmful residue in a food producing animal. A non-critical deficiency, which had produced or might produce a product which did not comply with its marketing authorisation.

Categorisation of Deficiencies

TGA satisfactory procedures for release of batches; and/or indicates a failure of the person responsible for QA/QC to fulfil his/her duties; and/or consists of several other deficiencies / non conformities, 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. Agreed proposed corrective actions including an implementation timeframe and or evidence of completion is required for each deficiency /nonconformity prior to a licence or OTHER DEFICIENCY certification being granted. Is a deficiency /non conformity critical or major, but indicates a departure from the applicable standard. Agreed proposed

PIC/S, TAIWAN PIC/S) a failure of the authorised person to fulfil his/her required duties; or 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.

MHRA, EMA, Person to fulfil his legal duties or 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.

WHO Geneva

A deficiency which cannot be major, but which indicates a departure from good manufacturing practice.

A deficiency which cannot be classified as either critical or major, but which indicates a departure from good manufacturing practice.

(Minor Deficiency) A deficiency where an observation made could improve the quality system and quality assurance approach of the manufacturer, but which

that cannot be classified as either classified as either critical or

Categorisation of Deficiencies

TGA corrective actions including an implementation timeframe is required for each deficiency /nonconformity before a licence or certificate is granted.

PIC/S, TAIWAN

MHRA, EMA, (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). Several related major or other deficiencies may be taken together to constitute a critical or major deficiency (respectively) and will be reported as such. All critical and major deficiencies found will be reported even if remedial action has been taken before the end of the inspection.

WHO Geneva did not have a major impact on the quality of the product.

Categorisation of Deficiencies

Nanjangud CRITICAL DEFICIENCY Deficiencies which have a high probability of causing adverse consequences to the patient or consumer may result in significant deviations in the safety, identity, strength or purity of the product; or are a combination of major deficiencies which indicates a critical MAJOR DEFICIENCY system failure. Deficiencies which could potentially cause adverse consequences to the patient or consumer if left un-addressed, could be considered indicative of poor control, could be considered major deviations by regulatory authorities, or a combination of minor deficiencies which indicate a major systems failure, or a number of repetitive minor MINOR DEFICIENCY deficiencies. A deficiency which cannot be classified as critical or major. Mostly minor deviations from the accepted practices or approved procedures.

Roorkee Having significant impact on product quality and safety and can have adverse impact on the patient and/or no therapeutic effect. E.g. Contamination /Cross Contamination evidence, wrong labelling.

CQA A deficiency having a significant impact on product quality, safety and efficacy and likely to have serious harmful effect or potential hazard on the patient.

Having impact or chances of impact on the product quality / safety but no direct threat of adverse effects on patient or therapeutic effect. E.g. Use of equipment beyond validated parameters but product passing in the required in process parameters.

A deficiency having an impact on product quality, safety and efficacy but unlikely to have adverse impact on the patient.

Having no impact on the product quality / safety directly. Minor deficiency raised shall be in the interest for inculcating a spirit of continuous improvement and strengthen quality system. Minor deficiencies may also have probable chances to raise concern of potential risk of threat to product quality / safety, if not

Any deficiency having no impact on the quality, safety and efficacy of product.

Categorisation of Deficiencies

Nanjangud

Roorkee attended appropriately. E.g. No training to the employees as per schedule / evidence of inappropriate cleaning of non process areas like change rooms.

CQA