Quality Assurance Of Pharmaceutical Products

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Quality Assurance of Pharmaceutical Products

This section sums up all activities and responsibilities required to ensure that the drug that reaches the patient is safe, effective and acceptable. Moreover, this section presents the national guideline for Good Storage and Distribution Practices as well as the related self assessment. The current Good Manufacturing Practices are also available for local manufacturers.

Good Governance for Medicines and Quality Assurance Programmes

Quality Assurance of Pharmaceutical Products Program: The Way forward

This monograph reviews the history and development of promoting a sound policy in public health in Lebanon, with particular reference to the efforts that lead to the establishment of the Quality Assurance of Pharmaceutical Products Program at the Ministry of Public Health in Lebanon in 2012. The steady involvement in the developmental work by Dr. Rita Karam is covered, and so is her supervision of the efforts leading to it. The presented monograph is well documented and supported by a list of rich references.

Quality Assurance of Pharmaceutical Products Program: The Way forward

Good Storage & Distribution Practices of Food Supplements in Lebanon

In line with the Good Storage & Distribution Practices of Pharmaceutical Products project that has brought core improvements at the level of the Lebanese pharmaceutical warehouses, the MoPH launches today through its Quality Assurance of Pharmaceutical Products program, the Good Storage & Distribution Practices of Food Supplements guideline.

The adequate storage and distribution of Food Supplements are a crucial activities to maintain their quality and integrity, to protect consumers from potential health risks and to ensure that they are not provided with misleading information.

Good Laboratory Practices for Pharmaceutical Quality Control Laboratories in Lebanon

The good laboratory practice provide advice on good practices for national pharmaceutical control laboratories involved in the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products.

These guidelines are consistent with the requirements of the WHO guidelines for good Laboratory practices and with the requirements of the International Standard ISO/IEC 17025:2005, and provide detailed guidance for laboratories performing quality control of medicines.
National pharmaceutical quality control laboratories usually encompass essentially two types of activity:

Compliance testing of APIs, pharmaceutical excipients and pharmaceutical products employing “ofﬁcial” methods including pharmacopoeial methods, validated analytical procedures provided by the manufacturer or validated analytical procedures developed by the laboratory;
Investigative testing of suspicious, illegal, counterfeit substances or products, submitted for examination by medicine inspectors, customs or police.

Good Storage and Distribution Practices of Pharmaceutical Products

Publication of the 5th edition of GSDP guidelines at ambient temperature, the 3rd edition Good Cold Chain Management for temperature-sensitive pharmaceuticals and self-assessment sheet for evaluation of the GSDP implementation.

Ensuring the quality, safety, and efficacy of pharmaceutical products during storage and distribution is paramount. Two essential guidelines on Good Storage and Distribution Practices (GSDP) are pivotal in this regard.

The first guideline "Good Storage and distribution Practices (GSDP) of Pharmaceutical products at ambient temperature" focuses on the proper storage and distribution of pharmaceuticals at ambient temperatures. It emphasizes the need for meticulous handling to maintain product integrity.

The second guideline, "Good Cold Chain Management for temperature-sensitive pharmaceuticals", underscores the importance of environmental controls. This guideline stresses the critical role of temperature control, requiring adherence to predetermined conditions supported by stability data.
Both guidelines are essential for maintaining product quality throughout the distribution network in addition to the self-assessment sheet for evaluation of the GSDP implementation.

These guidelines, issued by the Lebanese Ministry of Health, are crucial for all parties involved in the pharmaceutical supply chain. They provide a comprehensive framework for ensuring the quality and identity of pharmaceutical products throughout the distribution process. Adhering to these guidelines is paramount to avoid the introduction of counterfeit products into the marketplace. The guidelines align with the World Health Organization's recommendations, emphasizing their importance in maintaining the integrity of the distribution chain.

Guidelines 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:

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.

Biowaivers: Criteria And Requirements

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.

Regulations

Name	Type	Name(ar)	Caza	Investment Authorization Nb	Phone
St Georges Hospital	Private Hospitals	St Georges Hospital	Kesseroune	3407/1, 1/8/1983	09-234201 09-234212
Hospital MGR Cortbawi	Private Hospitals	Hospital MGR Cortbawi	Kesseroune	767/1, 7/6/1996	09/855410/1/2/3/4/5/6
Kesserwan Medical Center	Private Hospitals	Kesserwan Medical Center	Kesseroune
Hospital al Hajj	Private Hospitals	Hospital al Hajj	Kesseroune	207/1,6/7/1977	09/951755
Notre Dame de Liban Hospital	Private Hospitals	Notre Dame de Liban Hospital	Kesseroune	4/2, 4/1/1973	09-644644
Psychiatric Hospital of the Cross	Private Hospitals	Psychiatric Hospital of the Cross	El Meten	693/1-17/12/1971	04/710224
Arz Hospital	Private Hospitals	Arz Hospital	El Meten	2355/10/12/1982	01/876770?4
Eye & Ear Hospital International	Private Hospitals	Eye & Ear Hospital International	El Meten	(1/1498)11/9/1995	04/521130
Middle East Institutd Of Health	Private Hospitals	Middle East Institutd Of Health	El Meten	قرار رقم 1/476 تاريخ 18/ اب 2003	04/712111
Hopital Abou Jaouke	Private Hospitals	Hopital Abou Jaouke	El Meten	258-7-3----1961	04/718000 – 716000
SACH Medical Co.Bitar Hospital	Private Hospitals	SACH Medical Co.Bitar Hospital	El Meten	404/1---23/6/2004	03-774737 01-682300
Lebanise--Canadian Hospital	Private Hospitals	Lebanise--Canadian Hospital	El Meten	216631-14-9/2001	01/511487?9
Serhal Hospital	Private Hospitals	Serhal Hospital	El Meten	323/1---16/10/82	03-410100 04-405050
Centre Hopital de Behannss	Private Hospitals	Centre Hopital de Behannss	El Meten	203/1---1976	04/984009
Saint Joseph Hospital	Private Hospitals	Saint Joseph Hospital	El Meten	706-29/4/1952	01-240111
Haroun Hospital	Private Hospitals	Haroun Hospital	El Meten	09/12/1985 - n 4/2-1/203	01/897300-1-2-3-4
Belle Vue Hopital	Private Hospitals	Belle Vue Hopital	El Meten	66942--17/6/2009	01/682666
Hopital DAR AL Raheme?	Private Hospitals	Hopital DAR AL Raheme?	El Meten	1/165---21/3/1979	04/872211
Clinique du Levant SM	Private Hospitals	Clinique du Levant SM	El Meten	281/1---2/4/2009	01/501500
Hopital Notre dame pour les Malade Cronique	Private Hospitals	Hopital Notre dame pour les Malade Cronique	El Meten	692/1Dated 17 /12/1971	04/713100
Hopital Hayek	Private Hospitals	Hopital Hayek	El Meten	1/36-19/1/1974	01/499142
Hopital Beit Chabab	Private Hospitals	Hopital Beit Chabab	El Meten	1987/07/09 --قرار رقم 119	04-983393/4 04-981577
Clinique DE Chirugie Estetque Dr Nader Saab	Private Hospitals	Clinique DE Chirugie Estetque Dr Nader Saab	El Meten	517--15/6/2009	04/411111
Hopital Dr Toni Nassar Sal	Private Hospitals	Hopital Dr Toni Nassar Sal	El Meten	233/1--8/3/2010	03/233821
Alhamid Medical Center-Ghandour Hospital	Private Hospitals	Alhamid Medical Center-Ghandour Hospital	El Nabatieh	65/1-22/2/1992	07/760455 – 07/762542
Kalout Hospital	Private Hospitals	Kalout Hospital	El Nabatieh
AlCheick Harb Hospital	Private Hospitals	AlCheick Harb Hospital	El Nabatieh	yes	07/766799
Secours Populaire Hospital	Private Hospitals	Secours Populaire Hospital	El Nabatieh	147/1-2/7/1986	07/530970/1/2/3
Al Hikme Hospital	Private Hospitals	Al Hikme Hospital	El Nabatieh	1/31-27/1/2007	07/765362
Ghossein Hospital	Private Hospitals	Ghossein Hospital	El Nabatieh	1/168-1/2/2003	03/224402