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
C09CA07	TOLURA	G	Telmisartan - 80mg	80mg	Tablet	698,798 L.L
C10AA07	ROXARDIO	G	Rosuvastatin (calcium) - 20mg	20mg	Tablet, film coated	749,058 L.L
D10AF05	NAXIDERM	G	Nadifloxacin - 1%	1%	Gel	826,783 L.L
J01MA12	TAVAQUIN	G	Levofloxacin (hemihydrate) - 750mg	750mg	Tablet, film coated	1,389,533 L.L
L04AA32	APRIVA STARTER PACK	G	Apremilast - 10mg, Apremilast - 20mg, Apremilast - 30mg		Tablet, film coated	22,154,866 L.L
M01AH01	NORMOCOXIB	G	Celecoxib - 200mg	200mg	Capsule, hard	798,242 L.L
N06AX16	VENLAFAXINE BIOGARAN LP	G	Venlafaxine HCl - 75mg	75mg	Capsule, prolonged release	584,571 L.L
R03AK07	BUFOMIX EASYHALER	G	Formoterol fumarate dihydrate - 9mcg, Budesonide - 320mcg		Metered dose inhaler	2,365,163 L.L
S01AA12	TOBRACIN	G	Tobramycin - 0.3%	0.3%	Drops	322,522 L.L
A02BC04	RABEZOL 20	G	Rabeprazole sodium - 20mg	20mg	Tablet, enteric coated	282,847 L.L
A11CC05	ALTUM	G	Vitamin D3 - 50,000IU	50,000IU	Capsule, hard	712,620 L.L
B03AC	IVIRON	G	Iron (sucrose) - 100mg/5ml	100mg/5ml	Injectable concentrated solution	1,745,203 L.L
C10AA07	SINLIP	G	Rosuvastatin (calcium) - 20mg	20mg	Tablet, film coated	563,070 L.L
G04CA01	ALFOCIN	G	Alfuzosin HCl - 10mg	10mg	Tablet, extended release	858,779 L.L
J01DC04	CLORACEF FORTE	G	Cefaclor (monohydrate) - 250mg/5ml	250mg/5ml	Powder for suspension	632,950 L.L
M01AH01	REVCOX	G	Celecoxib - 200mg	200mg	Capsule	506,629 L.L
N04BC07	DACEPTON	G	Apomorphine HCl - 30mg/3ml	30mg/3ml	Injectable solution	13,404,432 L.L
N06AX16	VENLAX XR 75	G	Venlafaxine HCl - 75mg	75mg	Capsule, extended release	895,895 L.L
R03AK07	FORACORT 200	G	Formoterol fumarate dihydrate - 4.5mcg/inhalation, Budesonide - 200mcg/inhalation		Metered dose inhaler	2,159,555 L.L
S01AA12	TOBRASTILL	G	Tobramycin - 0.3%	0.3%	Drops solution	258,018 L.L
A02BC04	RABEZOL 20	G	Rabeprazole sodium - 20mg	20mg	Tablet, enteric coated	639,925 L.L
A11CC05	BIODAL	G	Vitamin D3 - 50,000IU	50,000IU	Tablet, film coated	1,110,014 L.L
C10AA07	SUPERSTAT	G	Rosuvastatin (calcium) - 20mg	20mg	Tablet, coated	517,379 L.L
G04CA01	ALFUZOSINE BIOGARAN LP	G	Alfuzosin HCl - 10mg	10mg	Tablet, coated, prolonged release	1,115,389 L.L
L01AA09	BENDAMUSTINE HYDROCHLORIDE	G	Bendamustine HCl - 100mg/50ml	100mg/50ml	Injectable powder for concentrate for solution	78,439,178 L.L
L04AA32	APRIVA	G	Apremilast - 30mg	30mg	Tablet, film coated	41,455,526 L.L
M01AH01	REVCOX	G	Celecoxib - 200mg	200mg	Capsule	506,629 L.L
N02BE01	PARACETAMOL ARROW	G	Paracetamol - 1g	1g	Tablet	80,631 L.L
N04BC07	DACEPTON	G	Apomorphine HCl Hemihydrate - 100mg/20ml	100mg/20ml	Injectable solution	12,678,532 L.L
N06AX16	VENLAX XR 75	G	Venlafaxine HCl - 75mg	75mg	Capsule, extended release	1,343,843 L.L

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