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

...

All

ATC	Name	B/G	Ingredients	Dosage	Form	Price
N03AX09	LAMOTRIGINE BIOGARAN	G	Lamotrigine - 25mg	25mg	Tablet, dispersible	595,322 L.L
A07DA03	LOPERAMIDE ARROW LAB	G	Loperamide HCl - 2mg	2mg	Capsule	442,124 L.L
C10AA08	LIVAZO	B	Pitavastatin - 2mg	2mg	Tablet, film coated	1,558,857 L.L
N05BA06	LORAZEPAM	G	Lorazepam - 2mg	2mg	Tablet, scored	485,063 L.L
L01BB04	LITAK 10	B	Cladribine - 2mg/ml	2mg/ml	Injectable solution	124,768,660 L.L
J01XX08	LINEZOLID ARROW	G	Linezolide - 600mg/300ml	2mg/ml	Injectable solution	13,282,147 L.L
J05AF05	LAMIVUDINE ARROW	G	Lamivudine - 300mg	300mg	Tablet, coated	7,850,907 L.L
A02BC03	LPZ-30	G	Lansoprazole - 30mg	30mg	Capsule, delayed release	360,150 L.L
G04BX14	LEJAM	G	Dapoxetine (hydrochloride) - 30mg	30mg	Tablet, film coated	1,269,931 L.L
N06AX21	LOXYT 30	G	Duloxetine HCl - 30mg	30mg	Capsule, delayed release	716,716 L.L
R05CA12	LIBLAB COUGH SYRUP	G	Dried Ivy leaf extract - 35mg/5ml	35mg/5ml	Syrup	237,860 L.L
N05BA08	LEXOTANIL	B	Bromazepam - 3mg	3mg	Tablet, scored	413,903 L.L
B01AB05	LOVENOX	BioTech	Enoxaparin sodium - 4,000UI (40mg)/0.4ml	4,000UI (40mg)/0.4ml	Injectable solution	886,936 L.L
J01MA14	LOXIMED	G	Moxifloxacin (HCl) - 400mg	400mg	Tablet	851,100 L.L
J01MA14	LOXIPHAR	G	Moxifloxacin (HCl) - 400mg	400mg	Tablet	1,063,555 L.L
N06AB04	LECITAL 40	G	Citalopram - 40mg	40mg	Caplet	1,761,778 L.L
C03CA01	LASIX	B	Furosemide - 40mg	40mg	Tablet	120,946 L.L
C10AA05	LIPODAR	G	Atorvastatin (calcium) - 40mg	40mg	Tablet, film coated	2,412,197 L.L
A02BC01	LOZICARE	G	Omeprazole - 40mg	40mg	Injectable powder for solution	12,446,972 L.L
C10AA05	LIPONORM	G	Atorvastatin (calcium) - 40mg	40mg	Tablet, film coated	1,491,665 L.L
C10AA05	LORVAST	G	Atorvastatin (calcium) - 40mg	40mg	Tablet, film coated	1,253,805 L.L
A02BC02	LUGANOR	G	Pantoprazole - 40mg	40mg	Injectable lyophilised powder for solution	463,050 L.L
A02BC02	LUGANOR	G	Pantoprazole - 40mg	40mg	Injectable lyophilised powder for solution	4,146,714 L.L
N05AE05	LAROZA	G	Lurasidone - 40mg	40mg	Tablet, film coated	5,548,726 L.L
N05AE05	LURABIL	G	Lurasidone - 40mg	40mg	Tablet, film coated	2,535,831 L.L
H02AB04	LISAMETHYLE	G	Methylprednisolone sodium succinate - 40mg/2ml	40mg/2ml	Injectable powder for solution+diluent	7,905,545 L.L
L01EX08	LENVIMA	B	Lenvatinib - 4mg	4mg	Capsule, hard	124,450,304 L.L
C10AA08	LIVAZO	B	Pitavastatin - 4mg	4mg	Tablet, film coated	1,835,305 L.L
L01EX08	LENVIMA	B	Lenvatinib - 4mg	4mg	Capsule, hard	L.L
R03DC03	LUKAST	G	Montelukast (sodium) - 4mg	4mg	Tablet, chewable	783,460 L.L

...