Pharmaceutical Guidelines

FDA (Food and Drug Administration)

FDA is an agency of the United department of Health and Human services. The FDA is responsible for protecting and promoting heath through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and OTC pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics and veterinary products.

Roles and Responsibilities of FDA:

⇨ Pre-marketing Control

⇨ Post-marketing control

⇨ Surveillance program for consumer's safety

⇨ Consumer education.

⇨ Technical Support and Cooperation wiyh other agencies

Function of FDA:

Responsible for protecting and promoting public heath through the regulation and supervision of pharmacrutical drugs.

Drug development process according to FDA:

1. Discovery and development

2. Preclinical Research

3. Clinical Research

4. FDA Review

5.FDA post market safety monitoring

GMP

GMP is the part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Aurhorization or product specification.

Main purpose of GMP:

Endure that products are consistently produced and controlled to the qualilty standards appropriate to their intended use and as required by product specification.

Basic requirements of GMP:

⇨ Suitable premises & Equipment.

⇨ Good traceability.

⇨ Consistent Manufacturing Procedures.

⇨ Practices Regulatory Monitored by Auditing.

⇨ Ability to investigate & Solve problem.

⇨ Accurate Testing Methods.

⇨ Adequate cleaning procedures

⇨ Correct Materials, Labels, and Containers.

⇨ Adequately trained staff.

⇨ Clearly Documented & Approved Procedures.

The 10 Golden Rules of GMP:

1. Get the facility design right from the start

2. Validate processes /সমস্ত Process গুলোকে Validate করা

3. Write procedures and follow them (Procesure লিখা এবং সেগুলো Follow করা)

4. Identify who does what (কে কী করতেছে তা Identify করা)

5. Keep good records (সমস্ত Record সংক্ষরণ করা)

6. Train and develop staff

7. Practice good hygiene / Good hygiene practice করা

8. Maintain facilities and equipment/ Facilities এবং Equipment গুলো Maintain করা

9. Build quality into the whole product lifecycle

10. Performing regular audit/ Regular Audit Perform করা

GMP Guidelines

⇨ ANVISA: Angencia Nacional de Vigilancia Sanitaria, Brazil (National Health Surveillance Agency, Brazil)

⇨ EMEA: European Medicines Evaluation Agency

⇨ ICH: International Conference on Harmonization

⇨ KFDA: Korea Food and Drug Administration.

⇨ MCC: Medicine Control Council, South Africa

⇨ MHRA: Medicine and Healthcare Products Regulatory Agency, UK

⇨ PIC: Pharmacrutical Inspection Convention

⇨ PIC/S: Pharmaceutical Inspection Cooperation Scheme (Scheme: A systematic plan for future action)

⇨ TPD: Therapeutic Product Directorate, Canada

GxP

GxP is a general term for Good (Anything..) Practice quality quidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries. The term GxP is frequently used to refer in a general way to a collection of quality guidelines.

Main purpose of GxP:

Main purpose is to ensure a product is safe and meets its intended use.

Purpose of GLP (Good Laboratory Practice):

To ensure uniformity, consistency, reliability, reproductivity, quality and integrity of products in development stage.

cGMP

cGMP refers to the current Good Manufacturing practice regulations enforced by the FDA. cGMPs provide for system that assure proper design monitoring and control of manufacturing processes and facilities. 

cGMP assures the identity, strength, quality and purity of drug products.

Main purpose of cGMP:

⇨ Assure proper design monitoring and control of manufacturing processes and facilities. 

⇨ Assure the identity, strength, quality and purity of drug products.

ICH

ICH is the short form of 'International conference on Harmonization' of technical requirements for registration of pharmacruticals for human use. ICH discuss scientific and technical aspects of drug registration. 

Purpose of ICH:

⇨ ICH's mission is to achieve greater harmonization (সমন্বয়) worldwide to ensure that safe, effective and high quality medicines are developed and registered.

⇨ The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. [Obviate ⇨ পরিহার করা]

ICH guidelines:

Q1: Stability

Q1A: Stability testing of new drug substances and product.

Q1B: Photostability testing of new drug substances

Q1C: Stability testing for new drug form.

Q1D: Bracketing and Matrixing designs for stability testing of new drug substances and product.

Q1E: Evaluation of Stability data.

Q1F: Stability data package for registration applications in climatic zones III and IV

Q2: Analytical Validation

Validation of analytical procedures: Text and methodology.

Q3: Impurities

Q3A: Impurities in new drug substances.

Q3B: Impurities in new drug products.

Q3C: Impurites: Guideline for residual solvents in new drug  products.

Q3D: Guideline for elemental impurities.

Q4: Pharmacopoeias

Q4A: Pharmacopoeial Harmonisation.

Q4B: Evaluation and recomendation of pharmaceutical texts for use in the ICH region.

Q5: Quality of Biotechnological Products

Q5A: Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.

Q5B: Analysis of the expression construct in cells used for production of r-DNA derived protein product.

Q5C: Stability testing of biotechnological/biological products.

Q5D: Derivation and characterization of cell substrates used for biotechnological/biological products.

Q5E: Comparibility of biotechnological/biological products subject to changes in their manufacturing process.

Q6: Specifications

Q6A: Test procedures and acceptance criteria for new drug substances and new drug products.

Q6B: Test procedures and acceptance criteria for biolechnological/biological products.

Q7: Good Manufacturing Practice

Good Manufacturing Practice guide for active pharmaceutical ingredients.

Q8: Pharmaceutical Development

Q9: Quality Risk Management

Q10: Pharmaceutical Quality System

Q11: Development & Manufacture of Drug Substances

Q12: Lifecycle Management

MHRA

The Medicines and Healthcare Products Regulatory Agency is a UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

Purpose of MHRA:

Ensuring that medicines and medical devices work and are accaptably safe.

Roles of MHRA:

⇨ Operate post-marketing surveillance for reporting, investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices.

⇨ Assessment and authorization of medicinal products for sale and supply in UK.

⇨ Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market.

⇨ Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.

⇨ Regulate clinical trials of medicines and medical devices.

⇨ Promote safe use of medicines and medical devices.

PIC and PIC/S

PIC and PIC/S are two international instruments between countries and Pharmaceutical inspection authorities.

PIC/S (Pharmaceutical Inspection Cooperation Scheme)

PIC/S is an instrument to improve co-operation in the field of Good Manufacturing Practies between regulatory authorities and the Pharmaceutical industry.

PIC (Pharmaceutical Inspection Convention)

⇨ It is an agreement between the health authorities of the European Union member states. 

⇨ It is convention as well as formal treaty between countries which has legal status.  [Convention⇨ রীতিনীতি)

⇨ By PIC, mutual recognition of inspection between countries are happened. [ Inspection⇨ পরিদর্শন]

Difference between PIC/S vs PIC

PICS: Pharmaceutical Inspection Cooperation Scheme

PIC: Pharmaceutical Inspection Convention

PIC/S is an informal arrangement between regulatory authorities.

PIC is formal arrangement between countries.

PIC/S has no legal status.

PIC has legal status.

PIC/S is an agreement between health authorities and Pharmacrutical company.

PC: Treaty between European countries/ Treaty between vountries

PIC/S: Exchange of information

PIC: Mutual recognition of inspections

ISO (International Organization for Standardization)

The International Organization for Standardization is an international standard setting body composed of representatives from various national standards organizations. (ISO9001:2000, ISO9001:2008, ISO9001:2015)

Purpose of ISO

⇨ The purpose of ISO certification is to achieve maximum commercial success.

⇨ Provides a framework and set of principles for organizational management.

Requirements for quality management system:

1. For documented procedures(ISO 9001: 2000)

⇨ Control of documents

⇨ Control of quality records

⇨ Internal audit

⇨, Control of non-conformity.

⇨ Corrective action

⇨ Preventive action.

For effective planning operations

⇨ Quality policy

⇨ Quality objective

⇨ Quality mannual

Other requirements

⇨ Process maps

⇨ Organizations charts

⇨ Internal communication.

⇨ Product schedule

⇨ Approved supplier list

⇨ Quality plans.

ISO Standards

⇨ ISO 9000 Standards: Quality Management Syatems in production environments

⇨ ISO 90001 Standard: Quality Management System

⇨ ISO 9001:2015⇨ Quality Management System Requirements

⇨ ISO 14001 standard: Environmental Management system

⇨ ISO 13403 Standard: Medical devices

DGDA (Directorate General of Drug Administration)

⇨ Directorate General of Drug Administration

⇨ The department is responsible for issuing licenses to pharmaceutical companies.

⇨ The Drug control committee of the department decides on drug registration.

⇨ DGDA supervices and implements all prevailing drug regulations in the country and regulates all activities related to import,  procurement of raw and packaging materials, production and import of finished drugs, export, sales, pricing etc of all kinds of medicines.

DCC ⇨ Drug Control Committee

NRA ⇨ National Regulatory Authority

R&D ⇨ Research & Development

ADR ⇨ Adverse drug Reactions

NCL ⇨ National Control Laboratory

DTL ⇨ Drug Testing Laboratory

BCSIR ⇨ Bangladesh Council of Scientific and Industrial Research

OTC ⇨ Over the Counter Drug

DGFDA ⇨ Directorate General of Food and Drug Administration

STG ⇨ Standard Treatment Guideline

BDNF ⇨ Bangladesh National Formulary

QAM ⇨ Quality Assurance Management

BNF ⇨ British National Formulary

ETP ⇨ Effluent Treatment Plant

Pharmaceutical Laws & Acts

⇨ Drug act-1940

⇨ Drug rules-1945

⇨ Drug rules-1946

⇨ Drug (Control) Ordinance-1982

⇨ The Drug (Control) (Ammendment) Ordinance-1984

DGDA recommended OTC drugs

1. Albendazole

⇨ Antacid

⇨ Ascorbic acid

⇨ Bacitracin

⇨ Benzyl benziate lotion

⇨ Calcium tablet

⇨ Chloramphenicol

⇨ Chlorhexidine

⇨ Chlorpheniramine

⇨ Diclofenac Gel

⇨ Dextromethorphen

⇨ Ferous fumarate

⇨ Ferous Gluconate

⇨ Ferous Sulphate

⇨ Gentamycin

⇨ Gentian violet

⇨ Glycerin suppositories

⇨ Low dose contraceptive pills

⇨ Mebendazole tablet

⇨ Methyl salicylate gel

⇨ Milk of Magnesia suspension

⇨ Multivitamin

⇨ Neomycin

⇨ Omeprazole

⇨ Oral rehydration salt

⇨ Paracetamol/ Acetaminophen

⇨ Permethrin

⇨ Potassium permanganate granules for gargle

⇨ Povidone Iodine

⇨ Promethazin theoclac

⇨ Ranitidin

⇨ Riboflavin

⇨ Sulbutamol

⇨ Salicylic acid + Benzoic acid ointment

⇨ Silver sulphadiazine ointment

⇨ Vitamin A capsule

⇨ Vitamin B complex

⇨ Xylomethazoline 0.1% normal drops

DGDA recommended Essential Drugs

1. Inhalational General Anaesthetics

⇨ Halothane

⇨ Nitrous oxide

⇨ Oxygen

2. Injectable General Anaesthetics

⇨ Thiopental Sodium

⇨ Ketamine

3. Local Anaesthetics

⇨ Bupivacaine

⇨ Lignocaine

⇨ Procaine

4. Preoperative medication & sedation for for short term Anaesthetics

⇨ Atropine sulphate

⇨ Morphine sulphate