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Intro To Validation

Validation is the procedure, process, or activity that is used in testing and then production must be validated in order to create documentary proof that it consistently maintains the desired level of compliance at all the stages. Any pharmaceutical facility's main goal is to consistently produce goods with the required qualities and attributes at the lowest costs. Although validation studies have long been carried out in the pharmaceutical sector.

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12 views4 pages

Intro To Validation

Validation is the procedure, process, or activity that is used in testing and then production must be validated in order to create documentary proof that it consistently maintains the desired level of compliance at all the stages. Any pharmaceutical facility's main goal is to consistently produce goods with the required qualities and attributes at the lowest costs. Although validation studies have long been carried out in the pharmaceutical sector.

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eknathahire05
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Validation

Validation is the procedure, process, or activity that is used in testing and then production must
be validated in order to create documentary proof that it consistently maintains the desired level
of compliance at all the stages. Any pharmaceutical facility's main goal is to consistently
produce goods with the required qualities and attributes at the lowest costs. Although validation
studies have long been carried out in the pharmaceutical sector, In order to obtain such a
quality, the pharmaceutical industry is today interested in a wide range of perspectives. The
term "validation" first appeared in the United States in 1978. The concept of validation has
evolved over time to include a wide range of activities, from computerized systems for clinical
trials, labeling, or process control to analytical methods used for the quality control of drug
substances and drug products. Validation is founded on regulatory requirements but is not
authorized by them, and is best viewed as a crucial and essential component of cGMP.
The 21 CFR parts 210 and 211 provide validation that is mostly based on FDA standards that
describe current good manufacturing practice (cGMP) for finished pharmaceuticals. According
to the cGMP regulations, manufacturing procedures must be planned and monitored to ensure
that raw materials used during production and the final product consistently meet
predetermined quality standards.

History of validation:
In an effort to raise the quality of medications, Ted Byers and Bud Loftus, are two FDA
officials, originally introduced the idea of validation in the middle of the 1970s. It was
proposed in direct response to several problems in the sterility of large volume parenteral
market. The primary validation efforts were focused on the production procedures for these
items, but they quickly expanded to the related medicinal operations. The FDA first suggested
the current GMP requirements in 1976. Since then, they have undergone various revisions.
GMP requirements are regarded as formal legislation in a number of significant nations, and
noncompliance is punishable by law. Additional compliance policies, manuals, and directives
are not binding on the law. However the pharmaceutical industry follows them as a part of
good management and business practice Although U.S.F.D.A. was the first to promote the idea
of process validation, the term did not appear in any of the agency's material until 29th
September, 1978. Process validation was not covered by any cGMP rules.
Benefits of validation:
 Processes that are consistently in control need less process support and have less
downtime.
 Only fewer batch failures and possibly more productive operations.
 Additionally, timely and adequate validation studies will demonstrate a dedication to
product quality, which could speed up the marketing permission process and pre-
approval inspection.
 Validation is a smart business move.
 Decrease in reworks and rejections
 Reduced testing time and final products.
 Faster and more precise process deviation analysis.

Need of pharmaceutical validation:


Since it involves systematically assessing systems, facilities, and processes to see whether they
carry out their intended activities efficiently and consistently, validation is a crucial component
of quality assurance. A validation method has been officially recognised because it has been
demonstrated to offer a high level of assurance that uniform batches will be generated that meet
the necessary criteria. Process improvement does not occur as a result of validation; rather,
validation verifies that a process has been created correctly and is being controlled. The
pharmaceutical industry employs highly skilled personnel, pricey materials, and material
removal facilities and technology.

Scope of Validation:
Finding the validation scope becomes a very challenging assignment because pharmaceutical
validation is a vast area of work that covers almost every component of pharmaceutical
manufacturing activities. But a careful review of the pharmaceutical processes will at least
highlight the following areas for pharmaceutical validation.
 Analytical
 Instrument Calibration
 Process Utility services
 Raw materials
 Packaging materials
 Equipment
 Facilities
 Manufacturing operations
 Product Design
 Cleaning
 Operators

Importance of validation:
 Lowering the cost of quality.
 Minimal batch failures, increased productivity, and efficiency.
 Decreased rejections.
 Avoiding investing on new equipment.
 Less complains regarding errors in the processes.
 Increased process knowledge among employees.
 Faster automation.
 New equipment starts up more quickly and consistently.
 Government regulation (Obtaining approval to manufacture and introduce new items
requires compliance with validation standards).
 Tests on finished goods and processes are reduced.

Team and responsibilities for validation:


Department/ Responsibility
Designation
Manager production Accountable for batch production, as well as for
reviewing reports and procedures.
manager QC You are responsibility is sample analysis.
Executive QC You are responsible for gathering and submitting the
sample to QC.
Executive production Responsible for batch manufacturing and protocol
development.
Manager QA My responsibilities include approving the procedure
and producing the summary report.

Figure: types of validation

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