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Guidelines for Good Storage and Distribution Practices of Pharmaceutical Products in Lebanon
Recruitment of Quality Auditors for Good Storage & Distribution Practices (GSDP)
Self-Assessment & Evaluation of Good Storage & Distribution Practices Implementation
Good Cold Chain Management for Temperature-Sensitive Pharmaceutical Products (Annex 1)- Edition 1
Self-Assessment & Evaluation of Good Cold Chain Management
Good Storage & Distribution Practices- Facility Questionnaire
Biowaivers: Criteria And Requirements
Checklist for BE Biowaiver Request
A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent.
The risk of therapeutic inequivalence of two immediate release products can never be reduced to zero, even if a full clinical study is performed. The conclusion of comparative clinical studies, in vivo bioequivalence studies, in vitro equivalence tests and biowaivers is based on statistics and scientific data that are assumed to be representative for the products at issue.
The aim of biowaiver guidance is to reduce the risk of bioinequivalence to an acceptable level. Pharmaceutical development work aims at reducing the probability of manufacturing inequivalent formulations taking into account the critical aspects of the product at issue. In this context, the absorption phase is regarded as the critical process determining the equivalence of the pharmacokinetic profiles and thereby the therapeutic equivalence of the test and reference product.
In this report we will focus on BCS-based Biowaivers. However, other type of biowaivers had been discussed in regulation.
>> Guides for the Drug Technical file submission: Module 3 (S and P Parts) and Module 5 (Bioequivalence Study)
The Drug Technical Document covers all the Quality, Safety and Efficacy information of a drug in a common format called the Common Technical Document (CTD). It has revolutionized the regulatory review processes, led to harmonized submission enabling the implementation of good review practices. For the pharmaceutical industries, it has eliminated the need to reformat the information for submission to the different regulatory authorities.
To improve the review and evaluation of the Module 3 and Module 5 of the Drug Technical file, the MOPH drafted the following 3 Guides:
Guide for the Quality Module 3- Part S - Drug Substance
Guide for the Quality Module 3- Part P - Finished Product
Guide for Bioequivalence - Module 5
These Guides are prepared by scientific experts and are intended to provide guidance and requirements for the preparation of the technical file to be submitted to the MOPH Technical Committee of Drugs. They are based on ICH standards and are useful for the Applicants of Generic Drug Technical file
Recruitment of Quality Auditors for Good Storage & Distribution Practices (GSDP)
Self-Assessment & Evaluation of Good Storage & Distribution Practices Implementation
Good Cold Chain Management for Temperature-Sensitive Pharmaceutical Products (Annex 1)- Edition 1
Self-Assessment & Evaluation of Good Cold Chain Management
Good Storage & Distribution Practices- Facility Questionnaire
Biowaivers: Criteria And Requirements
Checklist for BE Biowaiver Request
A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent.
The risk of therapeutic inequivalence of two immediate release products can never be reduced to zero, even if a full clinical study is performed. The conclusion of comparative clinical studies, in vivo bioequivalence studies, in vitro equivalence tests and biowaivers is based on statistics and scientific data that are assumed to be representative for the products at issue.
The aim of biowaiver guidance is to reduce the risk of bioinequivalence to an acceptable level. Pharmaceutical development work aims at reducing the probability of manufacturing inequivalent formulations taking into account the critical aspects of the product at issue. In this context, the absorption phase is regarded as the critical process determining the equivalence of the pharmacokinetic profiles and thereby the therapeutic equivalence of the test and reference product.
In this report we will focus on BCS-based Biowaivers. However, other type of biowaivers had been discussed in regulation.
>> Guides for the Drug Technical file submission: Module 3 (S and P Parts) and Module 5 (Bioequivalence Study)
The Drug Technical Document covers all the Quality, Safety and Efficacy information of a drug in a common format called the Common Technical Document (CTD). It has revolutionized the regulatory review processes, led to harmonized submission enabling the implementation of good review practices. For the pharmaceutical industries, it has eliminated the need to reformat the information for submission to the different regulatory authorities.
To improve the review and evaluation of the Module 3 and Module 5 of the Drug Technical file, the MOPH drafted the following 3 Guides:
Guide for the Quality Module 3- Part S - Drug Substance
Guide for the Quality Module 3- Part P - Finished Product
Guide for Bioequivalence - Module 5
These Guides are prepared by scientific experts and are intended to provide guidance and requirements for the preparation of the technical file to be submitted to the MOPH Technical Committee of Drugs. They are based on ICH standards and are useful for the Applicants of Generic Drug Technical file
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