3G System in 3G System in Pharmacy Pharmacy

Profession Profession

lokesh.shtty@riyadh.edu.dalokesh.shtty@riyadh.edu.da

3G System in 3G System in Pharmacy Pharmacy

Profession Profession

lokesh.shtty@riyadh.edu.dalokesh.shtty@riyadh.edu.da

GPP = Good Pharmacy Practice. Pharmacists responsibility and pharmacy requirements GLP = Good Laboratory Practice in what way drug testing (nonclinical and QC) to be done to achieve quality and reproducibility etc… eg: calibrationsGMP = Good Manufacturing Practice in what way pharmaceutical and cosmaceuticals to be manufactured.

GPP = Good Pharmacy Practice. Pharmacists responsibility and pharmacy requirements GLP = Good Laboratory Practice in what way drug testing (nonclinical and QC) to be done to achieve quality and reproducibility etc… eg: calibrationsGMP = Good Manufacturing Practice in what way pharmaceutical and cosmaceuticals to be manufactured.

3G outcome: Quality medicine to patient. More consideration on patient safety. Customer (Patient) Satisfaction.

3G outcome: Quality medicine to patient. More consideration on patient safety. Customer (Patient) Satisfaction.

GPP = Good Pharmacy Practice Applies to Pharmacy Drug Store. The way drug store has to be established & Role of Pharmacist in consideration to Legal and Ethical aspects.

GPP = Good Pharmacy Practice Applies to Pharmacy Drug Store. The way drug store has to be established & Role of Pharmacist in consideration to Legal and Ethical aspects.

What is Quality?What is Quality? Product with Same specifications time after time (Reproducibility or Uniformity Product with Same specifications time after time (Reproducibility or Uniformity

from batch to batch) from batch to batch) (Specification (Specification Qualitative and/or quantitative characteristics with test Qualitative and/or quantitative characteristics with test

procedures and acceptance limits, with which a given product must comply)procedures and acceptance limits, with which a given product must comply) Eg: hardness of tablet,Eg: hardness of tablet, Friability of tablet,Friability of tablet, Strenghth of tablet,Strenghth of tablet, Limit of impurities (limit test- arsenic, iron, sulphate, microorganisms……)Limit of impurities (limit test- arsenic, iron, sulphate, microorganisms……) Etc……………………..Etc…………………….. QUALITY CAN BE ACHIEVED THROUGH QUALITY CAN BE ACHIEVED THROUGH GMP & GLPGMP & GLP

GMP & GLP Applies to Pharmaceutical Production, Drug Research and Quality Control.

GMP & GLP Applies to Pharmaceutical Production, Drug Research and Quality Control.

WHY GMP & GLP?WHY GMP & GLP?

Assures (confirms) identity, quality, and strength of Assures (confirms) identity, quality, and strength of pharmaceuticals.pharmaceuticals.

Assure that correct procedures have been followed.Assure that correct procedures have been followed.

Provide documentation (is traceability when needed)Provide documentation (is traceability when needed) Overall IntentionOverall Intention::

To assure To assure Quality (Safety and efficacy)Quality (Safety and efficacy)

Without GMP Without GMP

WITH GMP HIGH QUALITY MEDICINE WITH GMP HIGH QUALITY MEDICINE

GLP NO ERROR BEST RESULT GLP NO ERROR BEST RESULT

GLP CALIBERATION & SOPminimizes instrument error GLP CALIBERATION & SOPminimizes instrument error

GLP & GMP Documentation Easy traceability of errorGLP & GMP Documentation Easy traceability of error

GLP and GMP (MAIN GOAL IS DOCUMENT EVRYTHING

EAZY TRACEABILITY)

GLP and GMP (MAIN GOAL IS DOCUMENT EVRYTHING

EAZY TRACEABILITY) GMP: GMP:

Protect the Quality of Protect the Quality of manufacturedmanufactured productproduct intended for intended for humanhuman useuse.. (MINIMUM REQUIREMENTS OF PHARM PLANT TO MAINTAIN (MINIMUM REQUIREMENTS OF PHARM PLANT TO MAINTAIN

QUALITY)QUALITY)

GLP:GLP: Protect the quality of Protect the quality of laboratorylaboratory datadata used to support a product used to support a product

application.application. (MINIMUM REQUIREMENTS OF PHARM LAB & NONCLINICAL LAB (MINIMUM REQUIREMENTS OF PHARM LAB & NONCLINICAL LAB

TO MAINTAIN QUALITY)TO MAINTAIN QUALITY)

GLP?

Set of established principles that provides

a framework within which laboratory studies are planned performed, monitored, reported and documented.

GLP?

Set of established principles that provides

a framework within which laboratory studies are planned performed, monitored, reported and documented.

Good Manufacturing Practices (GMP)Good Manufacturing Practices (GMP)

Must be current (Latest) ie, cGMP. Must be current (Latest) ie, cGMP.

For Pharmaceutical Preparation (Human and For Pharmaceutical Preparation (Human and animal use).animal use).

Regulations needed for manufacture Regulations needed for manufacture Pharmaceutical Products. Pharmaceutical Products.

Both GLP & GMP is framed by FDA.

FDA= Food and Drug Administration.In Saudi Arabia = SFDA or Saudi FDA

Both GLP & GMP is framed by FDA.

FDA= Food and Drug Administration.In Saudi Arabia = SFDA or Saudi FDA

Government Authorities World Government Authorities World Wide:Wide: Canada: Health CanadaCanada: Health Canada

Health Products and Food Health Products and Food Branch (HPFB)Branch (HPFB)

USA: Food & Drug Administration (USFDA)USA: Food & Drug Administration (USFDA)

Europe: EC DirectivesEurope: EC Directives

Saudi Arabia: FDASaudi Arabia: FDA

Food and Drugs Administration (FDA) Food and Drugs Administration (FDA) Provides Establishment licenseProvides Establishment license Conducts Regular InspectionsConducts Regular Inspections

Why are GMPs important?Why are GMPs important?

Government requirementGovernment requirement

Ensure quality productEnsure quality product

Reduce rejects, recallsReduce rejects, recalls

Satisfied customersSatisfied customers

Maintain manufacturing consistencyMaintain manufacturing consistency

Improves Company image and reputationImproves Company image and reputation

GMP GoalsGMP Goals SSafetyafety

Product is free of unwanted side effects when used appropriately by patientProduct is free of unwanted side effects when used appropriately by patient IIdentity dentity

Product exactly matches the labelling and related documentsProduct exactly matches the labelling and related documents SStrengthtrength

Product has correct concentration, potency or therapeutic activity of active Product has correct concentration, potency or therapeutic activity of active ingredientingredient

PPurityurity Product is free from contamination Product is free from contamination

QQualityuality Product meets all standards, expectations; performs as claimedProduct meets all standards, expectations; performs as claimed Product made consistentlyProduct made consistently

GMP CategoriesGMP Categories SaleSale PremisesPremises EquipmentEquipment PersonnelPersonnel SanitationSanitation Raw Material Raw Material

TestingTesting Manufacturing Manufacturing

ControlControl

Quality Control DepartmentQuality Control Department Packaging Material TestingPackaging Material Testing Finished Product TestingFinished Product Testing RecordsRecords SamplesSamples StabilityStability Sterile ProductsSterile Products Medical GasesMedical Gases

Sale of Drugs without GMP Punishable offense

Sale of Drugs without GMP Punishable offense No distributor and no importer shall sell a No distributor and no importer shall sell a

drug unless it has been fabricated, drug unless it has been fabricated, packaged/labeled, tested, and stored in packaged/labeled, tested, and stored in accordance with the requirements of FDA accordance with the requirements of FDA (GMP)(GMP)