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
Bchamoun Speciality Hospital	Private Hospitals	Bchamoun Speciality Hospital	Aley	829/ 27-8-2010	05-270970
Al Watani Hospital	Private Hospitals	Al Watani Hospital	Aley	قرار رقم 65 - 23/12/1980	05/557880/1/2/5
Lebanese Ophthalmic Hospital	Private Hospitals	Lebanese Ophthalmic Hospital	Aley	429 - 3/12/1981	05-557355
Medical 2000 Hospital	Private Hospitals	Medical 2000 Hospital	Aley	25- 10/1/2001	05-432525
Azounieh Hospital	Private Hospitals	Azounieh Hospital	Aley		05-220160
Al Jabal Hospital	Private Hospitals	Al Jabal Hospital	Aley		05-360555
Al Iman Hospital	Private Hospitals	Al Iman Hospital	Aley	280 - 1980	05/554264 – 555692
Bahman Hospital	Private Hospitals	Bahman Hospital	Baabda	رقم 1/4 بتاريخ 5/1/1999	01-545000 01-544000
Al-Rasoul Al-Aazam Hospital	Private Hospitals	Al-Rasoul Al-Aazam Hospital	Baabda		01/ 456456 - 452700
Sahel General Hospital	Private Hospitals	Sahel General Hospital	Baabda	1/15 26/01/79	01-858333/40
Specialized Medical Rehabilitation Hospital	Private Hospitals	Specialized Medical Rehabilitation Hospital	Baabda	108/1 -dated 14/04/1971	01-851934/5 01-852933
Sainte Therese Hospital	Private Hospitals	Sainte Therese Hospital	Baabda	1/29 - 23/02/1987	05/466780/2 - 463100
St Georges Hadath Hospital	Private Hospitals	St Georges Hadath Hospital	Baabda	1/50 - 25/02/1970	05-463922
Borj Hospital	Private Hospitals	Borj Hospital	Baabda	1/961 - 8/10/2010	01/474719
Hopital Saint Charles	Private Hospitals	Hopital Saint Charles	Baabda	1/65 - 21/02/1981	05/451100 – 953444
Sacre Coeur Hospital	Private Hospitals	Sacre Coeur Hospital	Baabda	1/366 - 24/09/1970	05/456293/4-457112/3
Al-Zahraa Hospital University Medical Center	Private Hospitals	Al-Zahraa Hospital University Medical Center	Baabda	1/408 - 17/08/1978	01-851040
Mount Lebanon Hospital	Private Hospitals	Mount Lebanon Hospital	Baabda	1/544 - 26/08/1998	05-957000
Al Hayat Hospital	Private Hospitals	Al Hayat Hospital	Baabda		01-277805
Clinique Dr. Georges Moarbes	Private Hospitals	Clinique Dr. Georges Moarbes	Baabda	1/243	01-389292/3/4/5
Hopital Francais - St Lourdes	Private Hospitals	Hopital Francais - St Lourdes	Baabda	1964, 1972	05/451100 – 953444
Ain Wzen Hospital	Private Hospitals	Ain Wzen Hospital	Al Chouf	6/2/1998 4021/710	05/509001/2/3/4
Alerfan Hospital	Private Hospitals	Alerfan Hospital	Al Chouf	20/4/1982 999/1	05-500877 05-501660
Hospital Almarkazi	Private Hospitals	Hospital Almarkazi	Al Chouf	1791/1 29/11/2000	07/970777
Osman Hospital	Private Hospitals	Osman Hospital	Al Chouf	270/1 1/6/2001	07/970000
BaakleenHospital	Private Hospitals	BaakleenHospital	Al Chouf	10/25/1980	05-300882/3
Hopital Maritime Jbeil	Private Hospitals	Hopital Maritime Jbeil	Jbeil	1981	09/540017
Hopital Saint- Michel Amchit	Private Hospitals	Hopital Saint- Michel Amchit	Jbeil	24/57-31/1/1966	09/621033/34
CHU Notre Dame de Secours Hospital	Private Hospitals	CHU Notre Dame de Secours Hospital	Jbeil	3749-5/11/2011	09-541700 - 1279 - 944255
Saint Louis Hospital S.A.L	Private Hospitals	Saint Louis Hospital S.A.L	Kesseroune	7616, 3/6/1996	09/933334