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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
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ATC Name B/G Ingredients Dosage Form Price
J05AB11 VALACICLOVIR ARROW G Valaciclovir - 500mg 500mg Tablet, film coated, breakable 2,889,261 L.L
L01CD02 DOCETAXEL GP PHARM G Docetaxel - 40mg/ml 20mg/0.5ml Injectable concentrated solution+diluent 4,567,721 L.L
L01XG01 BORTEZOMIB SPC G Bortezomib - 3.5mg 3.5mg Injectable powder for solution 15,743,401 L.L
L04AX04 LENOMA G Lenalidomide - 25mg 25mg Capsule, hard 15,343,847 L.L
M05BA06 BONAFOR G Ibandronic acid (monosodium monohydrate) - 150mg 150mg Tablet, film coated 383,955 L.L
N03AX09 LAMOTRIGINE BIOGARAN G Lamotrigine - 100mg 100mg Tablet, dispersible 1,233,647 L.L
N05AX12 PIRIFY G Aripiprazole - 15mg 15mg Tablet 795,555 L.L
N07CA03 ZINASEN G Flunarizine (HCl) - 10mg 10mg Tablet 599,354 L.L
S02CA06 AURICULARUM G Dexamethasone (sodium phosphate) - 10mg, Nystatin - 1,000,000IU, Oxytetracycline HCl - 90,000IU, Polymyxin B sulfate - 100,000IU Powder for suspension + solvent 755,239 L.L
A10BB12 DIAMERIL G Glimepiride - 4mg 4mg Tablet 322,522 L.L
B05BB02 5% DEXTROSE 0.9% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.9g/100ml Injectable solution 180,421 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS3 G Potassium chloride - K+:2.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.60 mmol/l, Sodium acetate - Cl-:112 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
C08CA01 AMLINE G Amlodipine - 10mg 10mg Tablet 662,962 L.L
C09DB07 CANDAM G Candesartan cilexetil - 16mg, Amlodipine - 5mg Capsule, hard 1,376,095 L.L
D03BA SERODASE G Serratiopeptidase - 5mg 5mg Tablet, enteric coated 460,938 L.L
J01DH02 AROPEM G Meropenem (trihydrate) - 0.5g 0.5g Injectable powder for solution 995,723 L.L
J05AB11 VALCYK BENTA G Valaciclovir - 500mg 500mg Tablet, film coated 4,318,214 L.L
L01XG01 VELZOME G Bortezomib - 3.5mg 3.5mg Injectable powder for solution 17,462,517 L.L
L04AX04 LIDAMID 25 G Lenalidomide - 25mg 25mg Capsule 87,161,381 L.L
N03AX09 LAMOTRIGINE NORMON G Lamotrigine - 100mg 100mg Tablet, dispersible/ chewable 2,284,532 L.L
N05AX12 XALIPRO G Aripiprazole - 15mg 15mg Tablet 2,418,917 L.L
N07X CEREBROLYSIN G Cerebrolysin - 215.2mg/ml 215.2mg/ml Injectable concentrated solution 2,303,346 L.L
R05CB06 MUCOVIC FORTE G Ambroxol HCl - 30mg/5ml 30mg/5ml Solution, sugar free 293,086 L.L
S02CA07 PAROTICIN G Fludrocortisone acetate - 1mg/ml, Polymyxin B (sulfate) - 10.000IU/ml, Lidocaine - 50mg/ml Drops solution 319,835 L.L
A10BB12 GLIM G Glimepiride - 4mg 4mg Tablet 628,918 L.L
B05BB02 5% DEXTROSE 0.9% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.9g/100ml Injectable solution 226,388 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS R G Potassium chloride - K+:1.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.40 mmol/l, Sodium acetate - Cl-:105.8 mmol/l, Sodium chloride - Na+:140.5 mmol/l Injectable solution L.L
C08CA01 AMLOCARD 10 G Amlodipine (besylate) - 10mg 10mg Tablet 870,298 L.L
C09DB07 CORONOPINE G Candesartan cilexetil - 16mg, Amlodipine - 5mg Capsule, hard 1,638,144 L.L
J01DH02 AROPEM G Meropenem - 0.5g 0.5g Injectable powder for solution 995,723 L.L
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