Finished Pharmaceutical Product definition

Finished Pharmaceutical Product means a medicine presented in its finished dosage form that has undergone all stages of production, including packaging in its final container and labeling. Good Manufacturing Practices (GMP) means the practices, which ensure that Finished Pharmaceutical Products are consistently produced and controlled according to quality standards appropriate to their intended use, and as required by applicable marketing authorizations. Health Products includes (i) Finished Pharmaceutical Products;(ii) durable health products (including but not limited to bednets, laboratory equipment, radiology equipment and supportive products); and (iii) consumable/single-use health products (including but not limited to condoms, rapid and non-rapid diagnostic tests, insecticides, aerial sprays against mosquitoes, breast milk substitute and injection syringes).

Finished Pharmaceutical Product means a product that has undergone all the stages of production, including packaging in its final container and labelling;

Finished Pharmaceutical Product means any chemical substance or product meant for the consumption of the end user;

Examples of Finished Pharmaceutical Product in a sentence

• The cost of any such sampling and testing of the Finished Pharmaceutical Product shall be borne by the Global Fund.

• If a Principal Recipient procures a Finished Pharmaceutical Product that has been recommended for use by the Expert Review Panel, the Global Fund will make the necessary arrangements for randomly selected samples of the Finished Pharmaceutical Product to be tested for Quality Control purposes, in accordance with advice provided by the Expert Review Panel, prior to the shipment and delivery of that product by the manufacturer to the Principal Recipient or other designated recipient.

• That is, the Principal Recipient may not place an order for that Finished Pharmaceutical Product under the contract more than 12 months after the contract is signed.

• If the Global Fund provides this confirmation, the Principal Recipient may enter into a contract with a supplier for the procurement of the alternate Finished Pharmaceutical Product that has been recommended for use by the Expert Review Panel at any time until the end of the ERP Recommendation Period, but the duration of the contract shall not exceed 12 months.

• The Certificate of Analysis shall include all aspects of the Finished Pharmaceutical Product testing and be aligned with the module certificate as approved by the regulatory authority.

• This includes, but is not limited to, the following:  Finished Pharmaceutical Product (FPP) formulation;  Method and site of manufacture;  Source and specifications of active and excipient starting ingredients;  FPP specifications;  Materials and specifications of the packaging (primary, secondary, pack size, label and package insert);  Shelf life and storage condition;  Product information.

• Stability and container closure system The re-test period of Dolutegravir sodium API is 60 months when packed in transparent polythene bags (purged with nitrogen), and outer black polythene bag and kept in HDPE drums with silica gel packers and stored at 25ºC, excursions permitted between 15ºC to 30ºC.Quality of the Finished Pharmaceutical Product FormulationDolutegravir is a pink, round, biconvex, film coated tablets debossed with ‘H’ on one side ‘D13’ on the other side.

• The WHO comparator product as identified on the programme’s website should be employed.• Comparative dissolution data will be reviewed during the assessment of the Quality part of the dossier.• As per the Quality guideline (Guideline on Submission of Documentation for a Multi-source (Generic) Finished Pharmaceutical Product (FPP): Quality Part, Appendix 1), comparative dissolution studies should be conducted in pH 1.2, 4.5, and 6.8 media.

• IN VITRO DISSOLUTION: STUDIES COMPARING DIFFERENT STRENGTHS OF THE TEST PRODUCT • Comparative dissolution data will be reviewed during the assessment of the Quality part of the dossier.• As per the Quality guideline (Guideline on Submission of Documentation for a Multi-source (Generic) Finished Pharmaceutical Product (FPP): Quality Part, Appendix 1), comparative dissolution studies should be conducted in pH 1.2, 4.5, and 6.8 media.

• Finished Pharmaceutical Product (FPP)Pharmaceutical developmentEach tablet contains 300mg TDF equivalent to 245mg of tenofovir disoproxil or 136mg of tenofovir.

More Definitions of Finished Pharmaceutical Product

Finished Pharmaceutical Product means a formulated and finished pharamaceutical product containing Lenacapacvir as the sole active ingredient as: (a) an injectable drug product containing 309 mg/mL Lenacapavir injection in a vial that is copackaged with device components required for dose administration in a vial kit configuration or (b) an oral tablet drug product containing 300mg of Lenacapavir.

Finished Pharmaceutical Product means any chemical sub- stance or product meant for the comsumption of the end user;