Quality assurance and Validation in Pharmaceutical

Industry• Quality assurance and quality management in

pharmaceuticals• ISO, WHO and US certification.

• Safety in microbiology laboratory.

Presented by Prajakta shinde Msc II microbiology

O In manufacturing safe, effective, reliable pharmaceutical products it is essential to follow certain guidelines and quality management protocols to assure drugs quality in accordance with human health

Quality assurance (QA)

O ISO 9000 defines as "part of quality management focused on providing confidence that quality requirements will be fulfilled".

O QA is applied to physical products in pre-production to verify what will be made meets specifications and requirements, and during manufacturing production runs by validating lot samples meet specified quality controls.

O is also applied to software to verify that features and functionality meet business objectives

O Quality assurance comprises administrative and procedural activities implemented in a quality system so that requirements and goals for a product, service or activity will be fulfilled

O It is the systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention

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ATTRIBUTE

QUALITY ASSURANCE

QUALITY CONTROL

Definition

QA is a set of activities for ensuring quality in the processes by which products are developed

QC is a set of activities for ensuring quality in products. The activities focus on identifying defects in the actual products produced.

Focus

QA aims to prevent defects with a focus on the process used to make the product. It is a proactive quality process.

QC aims to identify (and correct) defects in the finished product. Quality control, therefore, is a reactive process.

Goal The goal of QA is to improve development and test processes so that defects do not arise when the product is being developed.

The goal of QC is to identify defects after a product is developed and before it's released.

As a tool

QA is a managerial tool,QA is company based.

QC is a corrective tool,QC is lab based.

QUALITY ASSURANCE AND QUALITY CONTROL

Quality management O ensures that an organization,

product or service is consistent. O It has four main components:

quality planning, quality control, quality assuranceand quality improvement.

The quality-assurance and/or quality-control department should have the

following principal duties:O to prepare detailed instructions for each test and

analysis;O to ensure adequate identification and segregation

of test samples to avoid mix-up and cross-contamination;

O to ensure that environmental monitoring and equipment validation are

O conducted as appropriate for evaluating the adequacy of the manufacturing conditions;

O to release or reject raw materials and intermediate products, if necessary;

O to release or reject packaging and labelling materials and the final containers in which drugs are to be placed;

O Etc;

# A manufacturer's quality-control laboratory shall be separated from the production area and ideally should be in a separate building. The control laboratory should be designed and equipped and of such a size as to be a self-contained entity, with adequate provision for the storage of documents and samples, preparation of records and performance of the necessary tests. .

# In-process controls playa specially important role in ensuring the consistent quality of biological products. Tests that are crucial for quality control but that cannot be carried out on the finished product shall be performed at an appropriate stage of production. # Performance of all qualitative and quantitative tests mentioned in the specifications for starting materials may be replaced by a system of certificates issued by the producer of the starting material, provided that: there is a history of reliable production, the producer is regularly audited, and at least one specific identity test is conducted by the manufacturer of the final product.  

# Samples of intermediate and final products shall be retained in sufficient amount and under appropriate storage conditions to allow the repetition or confirmation of a batch control. However, reference samples of certain starting materials, e.g. components of culture media, need not necessarily be retained. # Certain operations require the continuous monitoring of data during a production process, for example monitoring and recording of physical parameters during fermentation. # Special consideration needs to be given to the quality-control requirements arising from production of biological products by continuous culture.

What is ISO?The International Organization for

Standardization (ISO) is an international standard-setting body composed of representatives

from various national standards organizations.O Certification:

International Organization for Standardization (ISO) does not certify organizations itself. Numerous certification bodies exist, which audit organizations and, upon success, issue ISO 9001 compliance certificates. Although commonly referred to as "ISO 9000" certification, the actual standard to which an organization's quality management system can be certified is ISO 9001:2008.

WHO CERTIFICATION SCHEME

O The WHO Certification Scheme for finished pharmaceutical products is an international voluntary agreement to provide assurance to countries participating in the Scheme, about the quality of pharmaceutical products moving in international commerce ;

WHO Certification scheme

O It is a Scheme developed by the World Health Organization (WHO) in response to the request of WHO Member States to facilitate international trade in pharmaceutical products between Member States.

O  was first developed in 1975. Since then it has been revised in 1988, 1992 and in 1997.

The Scheme operates as follows: 

1. The certificate recipient authority has in its national medicine legislation or guidelines a requirement for the

submission of a Certificate for a Pharmaceutical Product (CPP) for products being imported into the country as a support to ensure the quality of the product being imported. (In some

countries the CPP forms part of the dossiers to be submitted to the national medicine regulatory authority (NMRA) to have a

product registered by the authority). 

2. The applicant/importing company requests a CPP from the certifying authority through the exporting company.

 3.The certifying authority issues a CPP to the

importing/applicant company via the exporting company. (At the time of the development of the Scheme the understanding

was that a CPP would be sent directly to the recipient authority by the issuing authority. The practice at present is as shown in

the diagram.) 

Safety In microbiology laboratory:

O 1. Place all extra clothing, unnecessary books, purses, backpacks, and paraphernalia in an appropriate place. Racks are provided for these materials. The laboratory work area must be kept free of articles not actually in use.

O2. Eating, drinking, and smoking are forbidden at all times in the laboratory.

O 3. Keep your locker or laboratory door clean. Do not allow your locker drawer to become filled with cultures that have no value in your current work.

O 4. Return all reagents, cultures, and glassware to their appropriate places.

O 5. Wear a laboratory coat, smock, or lab apron when working in the laboratory. This will protect clothing from contamination or accidental discoloration by staining solutions.

6. Do not place anything in your mouth while in the laboratory. This includes pencils, food, and fingers. Learn to keep your hands away from your mouth and eyes.7. Avoid contamination of benches, floor, and wastebaskets.

8. Clean your work area (laboratory bench) with a phenolic disinfectant such as 5% Lysol or 5% phenol or a quaternary compound such as cetylpyridinium (Ceepyrn) before and after each laboratory period. This standard procedure lessens the chance for accidental infection as well as for contamination of cultures.

9. Special receptacles will be provided for infectious materials and used glass slides. Place all discarded cultures and contaminated glassware into these receptacles. Do not let unwanted and unneeded materials accumulate. Tall jars filled with a solution such as 5% Lysol or special receptacles will be provided for pipettes.

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10. When infectious material is accidentally spilled, cover it immediately with a disinfectant such as 5% Lysol or 5% phenol and notify your instructor at once.

11. Flame wire loops and needles before and immediately after transfer of cultures. Do not move through the laboratory with a loop or pipette containing infectious material.

12. Wash your hands thoroughly before and after each experiment, using disinfecting soap if possible

Refference:1) Harley-Prescott: Laboratory Exercises in Microbiology, Fifth Edition.2) Working document QAS/10.374 May 2010 WHO CERTIFICATION SCHEME ON THE QUALITY OF PHARMACEUTICAL PRODUCTS MOVING IN INTERNATIONAL COMMERCE3) Wikipedia.4) World Health Organization WHO Technical Report Series, No. 937, 2006