Good Manufacturing Practice (GMP) Interview Questions & Answers

  1. Question 1. Why Is The Code Of Gmp Changing From Time To Time?

    Answer :

    The TGA uses internationally harmonised manufacturing standards to allow manufacturers to operate in an international environment. The TGA maintains its GMP standards in line with updates issued through the PIC/S. Regular updates are necessary to maintain mutual confidence with regulators overseas and to promote quality assurance of inspections and harmonisation of technical standards and procedures with international inspection standards for the production and testing of medicinal products.

    Australian manufacturers benefit from reduced regulatory burden where the TGA is able to adopt harmonised international standards and establish mutual recognition agreements and cooperation arrangements with comparable overseas regulatory authorities.

  2. Question 2. When Did The Current Code Of Gmp Become Mandatory?

    Answer :

    The current Code of GMP was introduced on 29 July 2009 with a transition period up to 30 June 2010. It became mandatory from 1 July 2010.

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  4. Question 3. What Is Meant By ‘marketing Authorisation’?

    Answer :

    Marketing Authorisation is a set of regulatory requirements specified on the ARTG and any other requirements imposed by a relevant Delegate of the Secretary upon product listing or registration.

    Examples of regulatory requirements include, but are not limited to, compliance with registered formulations, special storage and transportation conditions, shelf life, labelling, batch release testing requirements etc.

    The Marketing Authorisation is equivalent to a Certificate of Registration or a Certificate of Listing for a medicinal product under the Therapeutic Goods Act 1989.

  5. Question 4. Is The Holder Of The Marketing Authorisation The Product Sponsor?

    Answer :


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  7. Question 5. Can A Sponsor Perform Release For Supply?

    Answer :

    Release for supply is defined as a manufacturing step for which a TGA licence is required. For this reason, a sponsor can only perform release for supply if the sponsor holds a TGA manufacturing licence. Refer to clause 1.1vii. of the 2009 Code.

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  9. Question 6. Can A Manufacturer Have More Than One Authorised Person To Perform Release For Supply?

    Answer :

    Yes – a manufacturer is allowed to have more than one authorised person to perform release for supply.

  10. Question 7. Do Product Quality Reviews (pqrs) Have To Be Conducted Yearly?

    Answer :

    Yes. However, if very few batches of one product are manufactured in one year, it may also be acceptable to conduct a two yearly PQR providing a rationale is documented and scientifically justified. The justification for a reduction in the frequency of reviews should consider whether the medicines are registered, listed or complementary, the number and size of batches manufactured, whether grouping is utilised  and the method of manufacture, together with an assessment of the risk associated with the product. The approach taken by the manufacturer will be assessed on a case-by-case basis.

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  12. Question 8. Can One Product Quality Review (pqr) Be Prepared For A Group Of Products?

    Answer :

    Grouping (sometimes referred to as bracketing or matrixing) of products for the preparation of PQRs may be acceptable, if adequately justified. It is usually only acceptable if the amount of batches manufactured annually for each product within the group is low, the grouped products are of the same pharmaceutical form containing the same or very similar active ingredients and are manufactured using the same equipment. Acceptability will be assessed during inspections on a case-by-case basis.

  13. Question 9. Do All Batches For Which Manufacture Has Commenced Have To Be Included In Product Quality Reviews (pqr)s?

    Answer :

    Yes. For example, also all batches for which the manufacture was terminated, delayed or has failed are expected to be included in the PQRs. When grouping is applied, all batches of all products in each group are expected to be included in the PQR.

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  15. Question 10. What Are The Requirements For Product Quality Review (pqr) For Products That Are For Export Only?

    Answer :

    The PQR requirements for products that are for export only are the same as the PQR requirements for all other products.

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  17. Question 11. What Are Language Requirements For Personnel?

    Answer :

    Manufacturers should define language requirements or standards and ensure personnel are proficient in the required language for their allocated tasks, particularly in relation to documenting and recording. Procedures employed to overcome identifiable deficiencies should also be documented.

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  19. Question 12. What Is The Definition Of ‘campaign’ Manufacture?

    Answer :

    Clause 5.19 defines campaign manufacture as being a separation in time of production. That is, manufacturing a series of batches of the same product in sequence in a given period of time and/or maximum number of batches followed by an appropriate (validated) cleaning procedure.

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  21. Question 13. What Environment Is Required For Sampling Primary Packaging Materials For Non-sterile Products? Can They Be Sampled In The Warehouse?

    Answer :

    Clause 3.9 also describes the physical requirements for the area being used to sample primary packaging material for non-sterile products. As product contact components, primary packaging materials should be sampled within an environment that adequately protects the packaging from contamination. The standard of air quality is optional and HVAC is not expected. However, sampling of primary packaging materials in an open warehouse would not be allowed.

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  23. Question 14. What Are The Requirements For Label Counting And Verification?

    Answer :

    Roll labels must be counted either on receipt or at issue. Supplier counts are not acceptable unless the supplier is specifically qualified and supplier certifies the exact count for each roll. Supplier numbering of labels is an acceptable alternative.

    Cut labels must be counted and effectively verified by the manufacturer because of risks of mix-ups.

  24. Question 15. Is It Necessary To Conduct On-going Stability Studies At A Gmp Certified Laboratory?

    Answer :

    No. However, the results from these studies are required to be reliable and meaningful. For that reason, other certificates may be used in lieu of a GMP certification, such as a current Good Laboratory Practice (GLP) certificate or licence issued by a regulatory authority acceptable to the TGA or a current ISO 17025 accreditation certificate. Stability test methods used by the laboratory should be appropriately validated and documented according to the requirements of the Code.

    The results from the on-going stability monitoring studies must be considered as part of release for supply, which is the final step in manufacturing.

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  26. Question 16. In The Case Of Imported Medicines, Is The Responsibility To Conduct An On-going Stability Monitoring Program With The Manufacturer Or With The Sponsor?

    Answer :

    The responsibility is with both the manufacturer and the sponsor. The manufacturer who carries out release for supply needs to ensure that the batch meets its Marketing Authorisation, and that an on-going stability monitoring program is conducted and data is available to support the expiry date. The sponsor is responsible for the Marketing Authorisation, ensures an on-going stability testing program is performed and has access to the stability results. In the contract manufacturing agreement, the responsibility for on-going stability may be contracted out to the manufacturer or other parties.

  27. Question 17. Is Grouping Of Products In The On-going Stability Program Acceptable?

    Answer :

    Grouping or bracketing could be acceptable, if appropriately scientifically justified and if the formulation is (nearly) identical. This will be assessed during inspections on a case-by-case basis.

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  29. Question 18. Are On-going Stability Data Reviewed During Inspections?

    Answer :

    Yes. During inspections, the operation of an appropriate on-going stability program are reviewed, including the results of on-going stability studies, where appropriate. If there are any concerns, the inspector can refer the evaluation to the regulator.

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  31. Question 19. Should The Results Of The On-going Stability Program Be Part Of The Release For Supply Process?

    Answer :

    Yes, the results of the on-going stability program are expected to be available to the Authorised Person who should consider those before releasing a batch for supply.

  32. Question 20. Is Annex 2 Applicable To The Manufacture Of Apis Used In Biological Medicinal Products?

    Answer :

    Yes. The manufacture of APIs for biological medicinal products for human use is usually performed in immediate conjunction with the manufacture of the biological medicinal product itself. For that reason, Annex 2 is written to cover both the API and the finished product manufacturing steps of biologicals. Additionally, Part II of the Code is applicable to the manufacture of APIs for biological medicinal products.

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  34. Question 21. What Are The Implications Of The New Code For Manufacturers Of Radiopharmaceuticals?

    Answer :

    The implications for radiopharmaceuticals manufacturers are similar to those for other medicines manufacturers. The Guide to interpretation of the 2002 Code for manufacturing the PET radiopharmaceutical Fludeoxyglucose [18F] Injection has been revised to reflect the 2009 Code.

  35. Question 22. Are Radiopharmaceuticals Supplied In A Hospital Situation Required To Be Entered In The Artg?

    Answer :

    Yes, except for radiopharmaceutical cold kits to which a radioisotope is to be added immediately before injection into patients. Registration is not required if the cold kit is manufactured in a public or private hospital for a patient of that hospital or a patient of another public or private hospital in the same State or Territory.

  36. Question 23. What Is Gmp?

    Answer :

    Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

    The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

  37. Question 24. Why Is Gmp Important?

    Answer :

    Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.

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  39. Question 25. Is Gmp Necessary If There Is A Quality Control Laboratory?

    Answer :

    Yes. Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.

  40. Question 26. Can Manufacturers Afford To Implement Gmp?

    Answer :

    Yes. Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.

  41. Question 27. Should The Scope And Extent Of Validation Be Based On Risk?

    Answer :

    Yes, the scope and extent of validation should be based on risk according to the manufacturer’s quality risk management procedures. Qualification and validation work is required to control the critical aspects of the particular operation and a common sense approach should be applied.

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  43. Question 28. Poor Quality Medicines Can Damage Health?

    Answer :

    A poor quality medicine may contain toxic substances that have been unintentionally added. 

    A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.