Quality Assurance Of Pharmaceutical Products

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

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All

ATC	Name	B/G	Ingredients	Dosage	Form	Price
N05AL05	SOLIAN	B	Amisulpride - 400mg	400mg	Tablet, film-scored	1,764,465 L.L
L01EA01	SAGITTA	G	Imatinib - 400mg	400mg	Capsule, hard	51,723,840 L.L
L01FG01	STIVANT	BioTech	Bevacizumab - 400mg/16ml	400mg/16ml	Injectable concentrate for solution	27,359,527 L.L
L01EX05	STIVARGA	B	Regorafenib - 40mg	40mg	Tablet, film coated	L.L
L01EX05	STIVARGA	B	Regorafenib - 40mg	40mg	Tablet, film coated	262,387,816 L.L
A02BC05	SOLEZOL	G	Esomeprazole - 40mg	40mg	Injectable powder for solution	301,021 L.L
A03AB06	SPASMOMEN	B	Otilonium bromide - 40mg	40mg	Tablet, film coated	438,093 L.L
H02AB04	SOLU MEDROL Act-O-Vial	B	Methylprednisolone sodium succinate - 40mg	40mg	Injectable powder for solution+diluent	313,115 L.L
M04AA03	STABURIC	G	Febuxostat - 40mg	40mg	Tablet, film coated	1,081,345 L.L
C10AA01	SIMVASTATIN NORMON	G	Simvastatin - 40mg	40mg	Tablet, film coated	264,737 L.L
C10AA01	SIMVASTATIN-REMEDICA	G	Simvastatin - 40mg	40mg	Tablet, film coated	780,772 L.L
C10AA01	STAVINE	G	Simvastatin - 40mg	40mg	Tablet, scored	207,336 L.L
C10AA03	STAVACOR	G	Pravastatin sodium - 40mg	40mg	Tablet, scored	891,799 L.L
L03AX03	SII-ONCO-BCG	G	Bacillus Calmette- Guerin Strain - 40mg/ml (1-8x10?CFU)	40mg/ml	Injectable dry powder	6,987,981 L.L
L04AC05	STELARA	BioTech	Ustekinumab - 45mg	45mg	Injectable solution	151,777,679 L.L
L04AC05	STELARA	BioTech	Ustekinumab - 45mg	45mg	Injectable solution	151,777,679 L.L
A07EC02	SALOFALK	B	Mesalazine - 4g/60ml	4g/60ml	Enema	3,796,355 L.L
G04CA04	SILOSIN	B	Silodosine - 4mg	4mg	Capsule	1,251,693 L.L
G04CA04	SILODOSINE ARROW	G	Silodosine - 4mg	4mg	Capsule	732,394 L.L
G04CA04	SILODOSINE BIOGARAN	G	Silodosine - 4mg	4mg	Capsule	555,007 L.L
R03DC03	SINGULAIR PEDIATRIC	B	Montelukast (sodium) - 4mg	4mg	Tablet, chewable	1,217,521 L.L
R03DC03	SINGULAIR PAEDIATRIC	B	Montelukast (sodium) - 4mg	4mg	Granules	1,248,430 L.L
B01AA07	SINTROM	B	Acenocoumarol - 4mg	4mg	Tablet	490,183 L.L
M03BX02	SIRDALUD	B	Tizanidine HCl - 4mg	4mg	Tablet	826,175 L.L
B05CX01	SERUFLEX DEXTROSE 5% INJECTION USP	G	Glucose - 5%	5%	Injectable solution	171,228 L.L
B05CX01	SERUFLEX DEXTROSE 5% INJECTION USP	G	Glucose - 5%	5%	Injectable solution	158,587 L.L
B05CX01	SERUFLEX DEXTROSE 5% INJECTION, USP	G	Glucose - 5%	5%	Injectable solution	171,228 L.L
B05CX01	SERUFLEX DEXTROSE 5% INJECTION, USP	G	Glucose - 5%	5%	Injectable solution	193,062 L.L
B05CX01	SOLUFLEX DEXTROSE 5% INJECTION USP	G	Glucose - 5%	5%	Injectable solution	186,167 L.L
B05CX01	SOLUFLEX DEXTROSE 5% INJECTION USP	G	Glucose - 5%	5%	Injectable solution	186,167 L.L

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