SEMINAR ONCONCEPTS OF PHILOSOPHY OF QA,GMP,GLP

PREPARED BY:- GUIDE BY:- PATEL BHAVIN RAJESH PARMAR M.PHARM SEM-1

DEPARTMENT OF QUALITY ASSURANCEA.P.M.C COLLEGE OF PHARMACEUTICAL

SCIENCE & RESEARCH,HIMMATNAGAR.

Contents

1.Quality Assurance 2.GMP 3.GLP

QUALITY ASSURANCE

Quality Assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of product.

“ It is the totality of the arrangement made with the object of ensuring that pharmaceutical products are of the quality required for their intended use”

QA is the heart and soul of the quality control. QA=GCP + GLP + GPP + GMP + any other

measure to achieve intended quality.

The system of Quality Assurance

Pharmaceutical products are designed and developed in a way that takes account of the requirement of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP)

Product and control operations are clearly specified in a written form and GMP requirements are adapted.

Managerial responsibilities are clearly specified in job descriptions.

Arrangements are made for the manufacture, Supply and use of correct starting and packaging material.All necessary controls on starting material, intermediate products and bulk products and other in process controls, calibrations , and validation are carried out.The finished product is correctly proceed and checked according to the defined procedure.Pharmaceutical products are not sold or supplied before the authorized persons have certified that each productions batch has been produced and controlled in accordance with the requirement of the marketing authorization and any other regulations relevant to the productions, control and release of Pharmaceutical products.

Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacture, distributed and sub-sequent handled so that Quality is maintained throughout their shelf life.There is a procedure for self inspection and/or quality audit that regularly appraises the effectiveness and applicability of the QA system.

QUALITY ASSURANCE-HIGHLIGHTS

Quality Assurance is independence of manufacturing.

In process quality is checked during manufacturing. Validation of facilities, Equipment ,

Process ,Products and cleaning as per master plan. Compliant handling. Storage of Quality record and control samples. Stability studies. Registration documents

Activities of Quality Assurance department

1. Technology transfer2. Validation3. Documentation4. Quality Improvement plans5. Assuring Quality of the Products

1. Technology transfer

Receipt of product design documents from research centre.

Distribution of documents received from the research centre.

Checking and approval of documents generated based on research centre document. i.e. batch manufacturing records.

Scale up and validation of product.

2.Validation:

Preparation of Validation plans for facility, equipments/process including cleaning.Approval of protocol for Validation of facility/equipments/product/process.Team member for execution of validation of facility/equipments/product/process

3. Documentation control:

Control distribution and achieving of documents.

Control of changes made by proper change control procedure.

Approval of document.

4. Quality Improvement plans:

Feedback received from the compliance team

Proposals for corrective and preventive actions

Annual products review Trend analysis of various quality

parameter for products , environment and water.

5. Assuring Quality of the Products: CGMP training SOP compliance Audit of facility for compliance Line clearance In-process counter checks Critical sampling Record verification. Release of batch for marketing Investigation of market complaints

GMP (Good Manufacturing Practice)

Definition

“Good Manufacturing Practice is that 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 authorization”

GMP is aimed primarily at diminishing the risks inherent in any pharmaceuticals production.

Such risks are essentially of two types:

(1)Cross contamination (in particular of unexpected contaminants)

(2)Mix-ups (confusion Caused by, for example, false labels being put on containers.

Under GMP All manufacturing process are clearly defined Qualifications and validation are performed All necessary resources are provided

(1) Appropriately qualified and trained personnel;

(2) Adequate premises and space;(3) Suitable equipment and services;(4) Appropriate materials, containers and labels;(5) approved procedures and instructions;(6) Suitable storage and transport;(7) Adequate personnel, laboratories and

equipment for in process controls;

Instructions and procedures are written Operators are trained to carried out

procedure correctly Records are made Storage and Distribution Recall Complaints

Objectives Conformance to the predetermined

specifications To eliminate errors To improve efficiency To reduce costs To prevent risks To minimize contamination To produce product of consistent quality

(GLP) GOOD LABORATORY PRACTICE

Definition

“A quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.”

Principles of GLP

To promote the development of quality test data and to provide a managerial tool to ensure a sound approach to the management

Set of criteria to be satisfied as a basis To allocate roles and responsibilities in

order to improvement To focus on those aspects of study

excretion

The GLP principles in their strict, regulatory sense apply only to such studies on pharmaceuticals which:

Are non-clinical, i.e. are mostly conducted in animals or in vitro, and include analytical aspects.

Are conceived to obtain data on the properties and/or safety with respect to human health and/or the environment of the testing substances.

Are intended to be submitted to a national registration authority for the purposes of registering or licensing the tested substance or any product derived from it.

In general and depending upon national legal requirements, the GLP requirements for non-clinical laboratory studies conducted for the safety evaluation in the field of drug safety testing cover the following classes of studies:

Single dose toxicity. Repeated dose toxicity (sub-acute and

chronic). Reproductive toxicity (fertility, embryo-

foetal toxicity and teratogenicity, perinatal /postnatal toxicity).

Mutagenic potential.

Carcinogenic potential. Toxicokinetics (pharmacokinetic studies

which provide systemic exposure data for the above studies).

Pharmacokinetic studies designed to test the potential for adverse effects (safety pharmacology).

Local tolerance studies, including photo toxicity, irritation and sensitization studies, and testing for suspected addictively and/or withdrawal effects of drug.

Scope Of GLP

Apply to the relevant studies planned and conducted in a manufacturer’s laboratories

Strict adherence to GLP will remove many sources of error and uncertainty

The requirement to formulate a study plan with a defined purpose of study will prevent false starts and diminish the incidence of incomplete or inconclusive studies.

Respecting the GLP principles will thus indirectly optimize the scientific yield of such studies.

References

Annex 4 GMP for pharmaceutical products, WHO

Guidelines

GLP , Handbook of GLP, Quality practices for

regulated non clinical research and development

How to practice GMPs 4th Edition By P.P. Sharma.

How to practice GLP By P.P.sharma , Vandana

Publication.