Interview Questions.

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

Answer :

The TGA uses internationally harmonised manufacturing standards to permit manufacturers to perform in an global environment. The TGA maintains its GMP requirements in step with updates issued through the PIC/S. Regular updates are necessary to preserve mutual self belief with regulators overseas and to sell exceptional guarantee of inspections and harmonisation of technical requirements and procedures with international inspection standards for the production and checking out of medicinal products.

Australian manufacturers gain from decreased regulatory burden wherein the TGA is capable of adopt harmonised international requirements and establish mutual recognition agreements and cooperation arrangements with similar distant places regulatory authorities.

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

Answer :

The modern Code of GMP became brought on 29 July 2009 with a transition period up to 30 June 2010. It became obligatory from 1 July 2010.

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Question three. What Is Meant By 'marketing Authorisation'?

Answer :

Marketing Authorisation is a set of regulatory requirements designated on the ARTG and any other necessities imposed by a applicable Delegate of the Secretary upon product list or registration.

Examples of regulatory requirements encompass, however are not restrained to, compliance with registered formulations, special storage and transportation situations, shelf existence, labelling, batch launch checking out necessities and so forth.

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.

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

Answer :

Yes

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Question five. Can A Sponsor Perform Release For Supply?

Answer :

Release for supply is described as a production step for which a TGA licence is needed. For this cause, a sponsor can handiest carry out launch for deliver if the sponsor holds a TGA manufacturing licence. Refer to clause 1.1vii. Of the 2009 Code.

Production and Operations Management Interview Questions
Question 6. Can A Manufacturer Have More Than One Authorised Person To Perform Release For Supply?

Answer :

Yes - a producer is authorized to have a couple of accredited character to perform launch for supply.

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

Answer :

Yes. However, if only a few batches of one product are manufactured in three hundred and sixty five days, it could also be ideal to conduct a  every year PQR offering a motive is documented and scientifically justified. The justification for a reduction inside the frequency of opinions have to recollect whether or not the medicines are registered, listed or complementary, the wide variety and size of batches synthetic, whether grouping is utilised  and the approach of manufacture, collectively with an assessment of the chance related to the product. The approach taken by using the producer might be assessed on a case-with the aid of-case basis.

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

Answer :

Grouping (every now and then called bracketing or matrixing) of merchandise for the practise of PQRs may be perfect, if properly justified. It is usually simplest suited if the quantity of batches manufactured yearly for each product within the institution is low, the grouped merchandise are of the identical pharmaceutical form containing the equal or very similar energetic ingredients and are synthetic the usage of the equal gadget. Acceptability will be assessed at some point of inspections on a case-with the aid of-case basis.

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

Answer :

Yes. For instance, additionally all batches for which the manufacture become terminated, behind schedule or has failed are predicted to be protected in the PQRs. When grouping is implemented, all batches of all products in every institution are predicted to be included inside the PQR.

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

Answer :

The PQR necessities for merchandise which are for export most effective are the same as the PQR requirements for all different merchandise.

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Question eleven. What Are Language Requirements For Personnel?

Answer :

Manufacturers have to outline language requirements or requirements and make sure employees are proficient within the required language for their allotted obligations, especially in relation to documenting and recording. Procedures hired to overcome identifiable deficiencies need to additionally be documented.

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Question 12. What Is The Definition Of 'marketing campaign' Manufacture?

Answer :

Clause five.19 defines campaign manufacture as being a separation in time of production. That is, production a chain of batches of the same product in series in a given period of time and/or most variety of batches observed by using the correct (proven) cleaning system.

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

Answer :

Clause three.Nine also describes the bodily requirements for the region being used to sample number one packaging material for non-sterile merchandise. As product contact components, primary packaging materials must be sampled inside an environment that accurately protects the packaging from infection. The widespread of air pleasant is optional and HVAC is not expected. However, sampling of number one packaging materials in an open warehouse would now not be allowed.

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

Answer :

Roll labels have to be counted either on receipt or at issue. Supplier counts are not ideal until the provider is specifically qualified and dealer certifies the exact matter for each roll. Supplier numbering of labels is an appropriate alternative.

Cut labels need to matter and correctly tested by way of the manufacturer because of risks of mix-ups.

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

Answer :

No. However, the outcomes from those studies are required to be reliable and significant. For that purpose, other certificates can be utilized in lieu of a GMP certification, which includes a modern-day Good Laboratory Practice (GLP) certificate or licence issued via a regulatory authority proper to the TGA or a contemporary ISO 17025 accreditation certificates. Stability check strategies used by the laboratory ought to be correctly confirmed and documented consistent with the requirements of the Code.

The consequences from the on-going stability monitoring research must be taken into consideration as part of launch for deliver, that's the very last step in manufacturing.

Quality Assurance Interview Questions
Question sixteen. 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 obligation is with each the manufacturer and the sponsor. The manufacturer who includes out launch for supply desires to make sure that the batch meets its Marketing Authorisation, and that an on-going stability tracking software is performed and statistics is available to guide the expiry date. The sponsor is answerable for the Marketing Authorisation, ensures an on-going balance trying out application is carried out and has get entry to to the stability effects. In the settlement manufacturing settlement, the obligation for on-going balance may be shriveled out to the manufacturer or other parties.

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

Answer :

Grouping or bracketing may be appropriate, if correctly scientifically justified and if the method is (almost) same. This could be assessed throughout inspections on a case-by means of-case basis.

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

Answer :

Yes. During inspections, the operation of the correct on-going balance program are reviewed, inclusive of the outcomes of on-going stability studies, in which appropriate. If there are any issues, the inspector can refer the assessment to the regulator.

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

Answer :

Yes, the consequences of the on-going stability application are expected to be available to the Authorised Person who must bear in mind the ones earlier than releasing a batch for supply.

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

Answer :

Yes. The manufacture of APIs for organic medicinal merchandise for human use is usually performed in immediate conjunction with the manufacture of the biological medicinal product itself. For that motive, Annex 2 is written to cover each the API and the completed product production steps of biologicals. Additionally, Part II of the Code is relevant to the manufacture of APIs for organic medicinal merchandise.

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

Answer :

The implications for radiopharmaceuticals manufacturers are just like the ones for other drugs manufacturers. The Guide to interpretation of the 2002 Code for production the PET radiopharmaceutical Fludeoxyglucose [18F] Injection has been revised to mirror the 2009 Code.

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 right now before injection into sufferers. Registration isn't always required if the bloodless kit is synthetic in a public or non-public health facility for a affected person of that health center or a affected person of some other public or personal hospital in the identical State or Territory.

Question 23. What Is Gmp?

Answer :

Good manufacturing practice (GMP) is a device for ensuring that merchandise are continually produced and controlled in step with first-rate standards. It is designed to limit the risks involved in any pharmaceutical manufacturing that can not be eliminated via testing the very last product.

The main dangers are: sudden infection of merchandise, causing damage to fitness or maybe death; wrong labels on boxes, that could mean that sufferers receive the wrong medication; insufficient or too much energetic ingredient, resulting in ineffective treatment or unfavorable effects.

Question 24. Why Is Gmp Important?

Answer :

Poor first-rate drugs aren't handiest a health threat, however a waste of cash for both governments and man or woman consumers.

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

Answer :

Yes. Good excellent ought to be constructed in at some stage in the producing technique; it can't be tested into the product afterwards. GMP prevents errors that can't be removed through excellent manipulate of the finished product. Without GMP it's far not possible to be sure that every unit of a medicine is of the equal exceptional as the devices of medication examined inside the laboratory.

Question 26. Can Manufacturers Afford To Implement Gmp?

Answer :

Yes. Making bad great products does not save money. In the longer term, it's far extra high priced finding mistakes once they have been made than preventing them inside the first place. GMP is designed to ensure that errors do now not arise. Implementation of GMP is an investment in right satisfactory medicines. This will improve the fitness of the character affected person and the community, in addition to reaping rewards the pharmaceutical enterprise and fitness professionals. Making and distributing bad fine drug treatments ends in lack of credibility for anybody: each public and personal fitness care and the manufacturer.

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 danger in line with the producer's exceptional danger management processes. Qualification and validation work is needed to control the crucial aspects of the precise operation and a commonplace feel technique have to be applied.

Food Resources Manual Interview Questions
Question 28. Poor Quality Medicines Can Damage Health?

Answer :

A bad first-class medication may additionally include poisonous substances which have been unintentionally introduced. 

A remedy that incorporates little or not one of the claimed factor will no longer have the supposed therapeutic effect.