The document discusses key concepts related to good laboratory practices including Good Manufacturing Practice (GLP), Good Laboratory Practice (GLP), the US FDA rules for GLP, OECD Guidelines for the Testing of Chemicals, ISO 9000 quality management standards, total quality management (TQM), quality review and documentation, validations, and process validation. GLP and ISO 9000 establish standards and guidelines to ensure uniformity, consistency, reliability, and quality in laboratory studies and testing. The US FDA and OECD provide specific rules and guidelines for GLP compliance. Validations are required to demonstrate equipment, facilities, and processes operate as intended to maintain compliance.

1. GOOD LABORATORY PRACTICES
SHRUTI PATIL
BACHELOR OF PHARMACY

2. • In the experimental research area, Good Manufacturing
Practice or GLP refers to a quality system.
 It ensures uniformity, consistency, reliability, reproducibility,
quality, and integrity of chemical non-clinical safety tests;
from physio-chemical properties through acute to chronic
toxicity tests.
 GLP was first introduced in New Zealand and Denmark in
1972 and
In the US in 1978, due to the industrial Bio-Test Labs scandal.
 GLP applies to non-clinical studies conducted for the
assessment of the safety or efficacy of chemicals to man,
animals, and the environment.

3. • Good Laboratory Practice embodies a set of principles that provides a
framework within which laboratory studies are planned, performed,
monitored, recorded, reported, and archived.
• These studies were undertaken to generate data by which the hazards and
risks to users, consumers, and third parties, including the environment, can be
assessed for pharmaceuticals (only preclinical studies), agrochemicals,
cosmetics, food additives, feed additives, and contaminants, novel food,
biocides, detergents, etc…..
• GLP helps assure regulatory authorities that the data submitted are a true
reflection of the results obtained during the study and can therefore be relied
upon when making risks/safety assessments.
• GLP is a data quality system so should not be confused with standards for
laboratory safety-appropriate

4. THE US FDA
• In the US FDA has rules for GLP in 21CFR58.
• Preclinical trials on animals in the United States of
America use their rules before clinical research on
humans.
• Research in the US not conducted under these
restrictions or research done outside the US not
conducted according to the OECD Guidelines might
be inadmissible in support of a New Drug
Application in the US.

5. OECD GUIDELINES FOR THE TESTING
OF CHEMICALS
• They were first published in 1981, and they are split
into five sections:
1. Section 1: Physical-chemical Properties
2. Section 2: Effects on the Biotic System
3. Section 3: Degradation and Accumulation
4. Section 4: Health Effects
5. Section 5: Other Test Guidelines
• Guidelines are numbered with three-digit numbers
• Section number is the first number
• Sometimes guidelines are suffixed with a letter.

6. ISO 9000
• The ISO 9000 (International Organization for Standardization 9000) family of
quality management system standards is designed to help organizations
ensure that they meet the needs of customers and other stakeholders
while meeting statutory and regulatory requirements related to the
product.
• The ISO 9000 deals with the fundamentals of the quality management
system
• ISO 9001 deals with the requirements that organizations wishing to meet
the standards must fulfil.

7. • ISO 9000 is headquartered in Geneva, Switzerland.
• Over one million organizations worldwide are
independently certified to meet the requirement of
ISO 9001
• ISO 9000 was first published in 9187 and based on the
BS 5750 series of standards from BSI (British
Standards Institution)

8. ISO 9000 SERIES QUALITY
MANAGEMENT PRINCIPLES
• ISO 9000 series based on eight quality management
principles
• The eight quality management principles are defined
in ISO 9000:200 Quality Management System-
Fundamental and Vocabulary
• ISO 9004:2009, Managing for the sustained success of
an organization- a quality management approach

9. • Principle 1 customer focus: Organizations depend on their customers and therefore
should understand current and future customers’ needs
• Principle 2 Leadership: leaders establish the unity of purpose and direction of the
organization
• Principle 3 Involvement of people: People of all levels are the essence of an
organization and their full involvement enables their abilities to be used for the
organization’s benefit
• Principle 4 Process approach: The desired results are achieved more efficiently when
activities and related resources are managed as a process.
• Principle 5 System approach to management: Identifying, understanding, and
managing interrelated processes as a system contributes to the organization’s
effectiveness and efficiency in achieving its objectives
• Principle 6 Continual improvement: continual improvement of the organization’s
overall performance should be a permanent objective
•

10. • Principle 7 Factual approach to decision-making
• Principle 8 Mutually beneficial supplier relationships: an organization and its suppliers
are interdependent and a mutually beneficial relationship enhances the ability of
both to create value.

11. TQM TOTAL QUALITY MANAGEMENT
• It is consists of organization
• It need wide effects to install and make permanent a
climate in which an organizations continuously
improves its ability to deliver high
• TQM efforts typically draw heavily on the previously
develop tools and techniques of quality control

12. QUALITY REVIEW AND QUALITY
DOCUMENTATION
1. Regulatory control
contain three regulatory classes
The regulatory control for each device class include:
I. General control(low to moderate risk)
II. General control and special control(moderate to high risk)
III. General control and premarket approval(high risk)

13. 2. General controls
general control is described in the following sections of the FD &C Act
501: Adulterated device
502: Misbranded device
510: Registration of producer of device
- establishment and registration and device listing
- premarket notification
- reprocessed single
516: Banned devices
518: Notification and other remedies
- notifications
- repair
- replacement
- refund
- reimbursement
- mandatory recall
519: Records and report device
- adverse event report

14. PHARMACEUTICAL ANALYSIS
• device tracking
• unique device identification system
• Reports of removal and corrections
520: general provisions respecting the control of devices intended
for human use
• custom device
• Restricted device
• Good manufacturing practice requirement
• Exemptions for devices for investigational use
• Transitional provisions for devices considered as new drugs
• Humanitarian device exemption

15. SPECIAL CONTROLS
• Special controls required forclass 2 devices
• performance standards
• postmarked surveillance
• Patient registries
• Special labeling requirements
• Premarket data requirement
• Guidelines

16. PREMARKET APPROVAL
• Under federal law class 3 devices are subject to the approval of premarket approval
application (PMA)devices
• Device that are not within a type marketed before the date of the Medical Device
Amendments of 1976 referred to preamendments devices
• Class 3 are automatically comes under federal law
• The FDA classified into class 3 devices intended to used in supporting or sustaining human
life or preventing impairment of human health

17. VALIDATIONS
• For medical device, food, blood products, biological product , tissue , establishment, clinical trials
conducting institutions we use the validation
• Validation is a process of establishing documentary evidence demonstrating that a procedure,
process, or activity carried out in production or testing maintains the desired level of compliance at
all stages.
• Validation required of food and drug, pharmaceutical regulating agencies like FDA’s good
manufacturing practices guidelines
• Subsections used in the validation:
1. Equipment validation
2. Facilities validation
3. HVAC system validation
4. Cleaning validation
5. Process validation
6. Analytical validation
7. Computer system validation
8. Packaging validation

18. THE VALIDATION PROCESS
• The validation scope , boundaries and responsibilities for each process or group of similar
processes or similar equipment's must be documented and approved in a validation plan.
• These documents, terms and reference for the protocol authors are for use in setting the scope of
their protocols. It must be based on a Validation Risk Assessment(VRA) to ensure that the scope
of validation being authorized is appropriate for the complexity and importance of the equipment
or process under validation
• The reference is that may affect the efficacy, quality and or records of the product are properly
qualified.

19. • Qualification includes the following steps:
• Design qualification(DQ)- demonstrates that the proposed design will satisfy all the
requirements that are defined and defined and detailed in the User Requirement
Specification(URS) satisfactory execution of the DQ is a mandatory requirement
before construction of the new design can be authorized.
• Installation qualification(IQ)- demonstrate that the process or equipment meets all
specification, is installed correctly, and all requirement components and
documentation needed for continued operation are installed and in place.
• Operational qualification(OQ)- demonstrates that all facets of the process or
equipment are operating correctly. Performance qualification(PQ)- demonstrate that
the process or equipment performs as intended in a consistent manner over time
• Component qualification(CQ)- is a relatively new term developed in 2005. this term
refers to the manufacturing of auxiliary components to ensure that they are
manufactured t the correct design criteria. This could include packaging components
must have some type of random inspection to ensure that the third party
manufacturer’s process is consistently producing components that are used in the
world of GMP at drug or biologic manufacturer.

20. PROCESSED VALIDATION
• Process validation is the analysis of data gathered throughout
the design and manufacturing of a product in order to confirm
that the process can reliably output products of a determined
standards.
• Regulatory authorities like EMA and FDA have published the
guidelines relating to process validation.
• The purpose of process validation is to ensure varied inputs lead
to consistent and high quality outputs
• Process validations an ongoing process that must be frequently
adapted as manufacturing feedback is gathered.
• End to end validation of process is essential in determining
product quality because quality cannot always be determined by
finished product inspection
• Process validation can be broken down into 3 steps: process
design, process qualification, and continued process verifications

21. VALIDATION OF EQUIPMENT
• Validation first developed for equipment and process.
• In 1993 the software for a large-radiotherapy device
was not designed and tested properly.
• Several problems resulted in several devices giving
doses of radiation higher than intended
• So many patients died and several got permanently
injured that is why validation of equipment is
required for pharma Industry following are the steps
followed to do validation of equipment in SAP and
how create link between maintenance Order and
calibration order.