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Pharmaceutical Validation Guide: March 2013
Validation Practices and Procedures
The procurement process normally starts with the production of a documented requirement or group of requirements. For existing facilities this should take the form of a CHANGE REQUEST (CR). As soon as management has agreed to proceed with the CR, approval should be issued to produce a Validation Plan (VP). This plan must be all encompassing. It must give assurance that all aspects of the proposed CR have been studied and the CR impact on existing facilities, utilities, product and personnel have been defined and the approptiate corrective or support actions planned for. A fully detailed User Requirements Specification (URS) can now be authoured reviewed and published. Since developing the URS may raise problems that could not be anticipated when the VP was raised; a VP review is required to ensure all aspects of the final approved URS are fully catered for.
With the URS defined and the Validation Plan (VP) in deveopment Validation Risk Assessment VRA) must be authored and executed to establish the scope and depth of CNC validation that is appropriate for this equipment. This information must be published in the VP and used as the authority for all protocol development. Where vendor developed Functional Specifications FS) and or Design Specification (DS), are available they should be reviewed and referenced in the VP. Where these documents are not available a DS or FS may have to be retrospectively developed.
When the DS or FS that is to be used are defined, a pre-approved Design Qualification (DQ). The execution of this DQ must verify that the proposed design will;
The installation of each validatable item and or system must be subjected to, and satisfy, a pre-approved Installation Qualification (IQ) protocol. Details of the scope of the IQ, responsibilities for generating, reviewing and approving of this document must all be documented in the VP.
When the requirements of the IQ have been satisfied, all aspects of the operational capabilities of each system must be fully challenged and verified by the execution of a pre-approved Operational Qualification(OQ) protocol. As with the IQ; OQ scope and details of the persons responsible for generating, reviewing and approving of this document will be documented in the VP.
As soon as the executed IQ and OQ protocols having been reviewed and approved, a pre-approved Performance Qualification (P1Q) protocol or Process Qualification P2Q) (this requirement will be documented in the VP) must be issued for execution.The execution of this PQ must verify that the system performance requirements, as specified in the URS have been achieved, and that the system operates in a manner safe to the product and production personnel.
Labels: Intelligence, Intelligence quotient, IQ Tests, Psychology, Smart Fortwo, Social Sciences, Toyota, Validation (drug manufacture), Validation Practices and Proceedures
cGMP Validation Scope
cGMP Validation requires the following procedures, processes and designs changes to be documented, approved and issued by Change Control . Once in use these procedures must be subjected to strict change control procedures and a rigorous system of routine and random audits that will produce documented evidence that these procedures are correct and are being applied in all aspects of cGMP compliance requirements. (21 CFR Part 820.70 relates). (21 CFR Part 211.100(a) relates).
Operators must receive sufficient training to enable them to proficiently and diligently work in accordance with these document procedures. (21 CFR Part 820.25(b) relates). (21 CFR Part 211.25(a) relates).
Documented directives and techniques must be written in clear and unequivocal language. Within the industry these instructions are referred to as Standard Operating Procedures or SOP?s. (21 CFR Part 70(1) relates). (21 CFR Part 211.)
Production records that record and therefore verify that all the specified manufacturing parameters; either manually observed or electronically recorded, have been complied with must be identified with all the relevant product identifications and securely retained. (21 CFR Part 820(2) relates) (21 CFR Part211.100(b) relates).
All deviations from these documented expectations that occur during product processing thoroughly investigated and the findings documented. (21 CFR Part 820.70 relates).
All records generated during manufacturing and distribution that are mandated as essential in establishing the entire manufacturing history of a product batch; to be traced, must be kept and retained in a secure, comprehensible and readily accessible form. (21 CFR Part 820.180(b) relates) (21 CFR Part 211.110(c) relates)
Product distribution, transit and storage conditions must ensure that the product efficacy, quality and records are never compromised. (21 CFR Part820.140 relates). (21 CFR Part 211.180(a) relates)
There must be a system in use that ensures all complaints about marketed products are promptly and diligently examined and the causes of quality defects investigated. (21 CFR Part 820.100(a) relates). (21 CFR Part 211.198(a) relates)
Where statistical analysis is used to verify the acceptability of a process capability, then there must be documented validation of the robustness and accuracy of this analysis procedure. (21 CFR Part 820.250(a) relates). (21 CFR Part 211.160(a) relates).
cGMP Validation Audit
AUDIT PREPARATION - For CGMP validation audit the Quality Auditor (team leader) must review all applicable change control records subsequent to a design transfer, any FDA clearance delay information, recall records, standard manufacturing procedures, device histories, complaint history, device labels and inserts, previous audits with results, follow-up audits, plus any other document relative to the audit.
AUDIT INITIATION - The Quality Auditor prepares/updates an audit checklist for systematic examination of the area to be audited, informs the Manager of the department being audited at the start of the audit, and reviews observations with the Department Manager.
AUDIT ANALYSIS - The Quality Auditor reviews the data gathered, verifies important details, and writes an audit report according to the format delineated in the attached audit report outline.
ISSUANCE OF AUDIT REPORT - The Quality Auditor issues the written audit report to the President and Department managers within three working days following completion of the audit. If conditions are critical, the Director of Quality Assurance shall verbally brief appropriate staff members within 12 hours following audit completion. Audit reports shall be stamped "Confidential".
CORRECTIVE ACTION - The appropriate Management staff member shall be responsible for developing a schedule for correcting deficiencies cited in the audit report and submitting same within five working days to the Quality Assurance Manager. Included in the correction schedule shall be the responsible individual, and the date when corrective action will be completed. The Manager of Quality Assurance shall act as arbiter, if necessary, to judge validity of the deficiency, responsible individual, and reasonable date to complete the corrective action.
GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition - Volume 1 With Checklists and Software Package
Leonard Steinborn
Audit by Mail: Time and Cost Effective GMP Audit Tool
CALISO eLearning
Miscellaneous: See all 1 items
GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their Suppliers, Sixth Edition, (Volume 1 - With Checklis
GMP audit leads FDA to IOL firm's monitoring.(Medical Development Research)(Brief Article): An article from: Bioresearch Monitoring Alert
AUDIT FOLLOW-UP - The Quality Auditor maintains a log listing deficiencies, responsible individual, target date for corrective action, and actual date of correction. If the same deficiency occurs on a second follow-up audit, the President shall be notified in writing by the Quality Assurance Manager.
LOG OF AUDITS AND FOLLOW-UP AUDITS - The master log shall be maintained by the Senior Quality Auditor. The audit log file shall include a copy of current audits, list of areas to be audited during the 12-month period, and list of areas audited to date (i.e., part of the Master Log).
Labels: Audit, Auditor's report, Corrective and preventive action, Food and Drug Administration, Management, Quality Assurance, Quality Assurance Manager, Quality management system
Validation of Pharmaceutical Process Equipment1
Validation, as it is known today, has developed from the need to maintain quality,
consistency, and above all,
public safety. Validation is a rapidly growing and evolving
subject. This evolution stems from technology’s astonishing growth rate, especially in
terms of what is available in computer hardware and software. Over the past 15 years,
nd process control through the use of a computer has caused
additional concerns relating the validation of the processing system. Today, the computer
is used for everything from controlling the process, to automatically providing batch
reports, and providi
ng automated quality control.
The foundation of validation, the methodology behind validation, and the need for
validation will likely remain a key aspect of the industry we work in. This session reflects
the current industry trends and serves as an educ
ational tool in our progressive industry.
These key terms are listed for your use in this session:
FDA definitions of Validation
“There shall be written procedures for production and process control designed to
assure that th
e drug products have the identity, strength, quality, and purity they
purport or are represented to possess.”
FDA Guideline “General Principles of Validation”, May 1987
“Establishing documented evidence which provides a high degree of assurance
that a spe
cific process will consistently produce a product meeting its pre
determined specifications and quality attributes.”
The key idea is to provide a high level of documented evidence that the equipme
process conform to a written standard. The level (or depth) is dictated by the
complexity of the system, process, or equipment. The validation “package” must
provide the necessary information and test procedures required to prove that the
em and the process meet the specified requirements.
“Installation Qualification”
Verification that the equipment/system is installed in a
proper manner and that all of the devices are placed in an environment suitable for
their intended operations.
“Operational Qualification”
Verification that the equipment performs as
expected throughout the intended range of use.
“Process Qualification”
Verification that the system is repeatable and
consistently producing a quality product.
A set of instructions that outline the organization of the Qualification
Documents. The protocol specifies the type of tests required and the order in which
the tests should be conducted.
3. Validation Life
What does vali
dation mean to the personnel in your company? What does validation
mean to your vendor?
Where does the responsibility lie for validation?
“FDA , End user, or Vendor?”
Process Validation vs. Equipment Validation vs. Validation Plan?
ce between the three?
Validation is a continuing and evolving process. The validation process extends from the
very basic specifics (how each item works and interacts with another item) to a very broad
theological and methodical investigation of how the s
ystem and processes perform. Its
scope encompasses documentation, revision control, training, and maintenance of the
system and process. Evidence of validation should be seen at the corporate level, and be
reflected in the management structure. Validatio
n is not just a set of procedures and rules
to satisfy FDA, validation is a method for building and maintaining
Phillip A. Cloud
When Does Validation Begin?
During the chemical development stage?
When you are currently developing a process?
When conducting clin
ical studies?
Ideally, validation starts in the very beginning, in the laboratory. In the lab, scientists
discover exactly how the product reacts, as well as the parameters that are required to
produce such a product. They learn under what conditions the p
roduct fails or becomes
unstable, unusable, and when its quality begins to suffer. Once the laboratory has
established the boundary processing criteria, this information can then be used for
establishing requirements for validation.
When Does Validation
After installation of the equipment?
After the initial validation?
After the first successful batch?
Validation of a system never truly ends. Once a new system and process have been
validated, the system still requires maintenance, periodic calibrat
ions and adjustment.
Therefore, the process [and consequently validation] is always under scrutiny and
constant evaluation. Session 2 will discuss when revalidation is required and how it fits
into a master validation protocol plan.
Shown on the follow p
age is a simplified flowchart of a validation life cycle. This flowchart
has been modified to show just one part of a project rather than the entire validation plan.
The first step involved in validating a new process is to formulate a good definition of
This means defining the following:
How the elements of the system link together to perform the final process
Once the process has been completely defined, equipment usually will be requir
perform the actual processing of the product. This equipment will be collectively called
“The System”. The system and its operations can then be identified and defined.
Labels: Automation, Business, Japan, Manufacturing, PR Newswire, Process control, Quality control, SCADA
APPROACHES TO PROCESS VALIDATION
There are two basic approaches to the validation of process itself (apart from the qualification of equipment used in production, the calibration of control and
measurement instruments, the evaluation of environmental factors, etc). These are the experimental approach and the approach based on the analysis of historical data. The experimental approach, which is applicable to both prospective and concurrent validation, may involve:
1. extensive product testing,
2. simulation process trials,
3. challenge/worst case trials, and
4. Control of process parameters (mostly physical)
One of the most practical forms of process validation, mainly for non-sterile products, is the final testing of the product to the extent greater than that required in routine quality control. It may involve extensive sampling, far beyond that called for in routine quality control and specifications, and often for certain parameters only. Thus, for instance, several hundred tablets per batch may be weighed to determine unit dose uniformity. The results are then treated statistically to verify the normality of the distribution and to determine the standard deviation from the average weight. Confidence limits for individual results and for batch homogeneity are also estimated. Strong assurance is provided that samples taken at random will meet regulatory requirements if the confidence limits are within compendia specifications.
THE PHARMACEUTICAL PROCESS EQUIPMENT
The key idea of validation is to provide a high level of documented evidence that the equipment and the process conform to a written standard. The level (or depth) is dictated by the complexity of the system or equipment. The validation package must provide the necessary information and test procedures required to provide that the system and process meet specified requirements. Validation of pharmaceutical process equipment involves the following :
1. Installation Qualification: This ensures that all major processing and packaging equipment and ancillary systems are in conformity with installation specification, equipment manuals schematics and
engineering drawing. It verifies that the equipment has been installed in accordance with
manufacturer’s recommendation in a proper manner and placed in an environment suitable for
2. Operational Qualification: This is done to provide a high degree of assurance that the equipment
functions as intended. Operational qualification should be conducted in two stages:
3. Component Operational Qualification, of which calibration can be considered a large part.
4. System Operational Qualification to determine if the entire system operates as an integrated whole.
5. Process Performance Qualification: This verifies that the system is repeatable and is consistently producing a quality product
These exercises assure, through appropriate performance lists and related documentation, that
equipment, ancillary systems and sub-systems have been commissioned correctly. The end results are that all future operations will be reliable and within prescribed operational limits. At various stages in a validation exercise there are needs for protocols, documentation, procedures, specifications and acceptance criteria for test results. All these need to be reviewed, checked and authorized. It would be expected that representatives from the professional disciplines,
e.g., engineering, research and development, manufacturing, quality control and quality assurance are
actively involved in these undertakings with the final authorization given by a validation team or the quality assurance representative
The concept of process validation from its beginnings in the early 1970s through the regulatory aspects associated with current good manufacturing practice (cGMP) regulations and the application thereof to various analytical, quality assurance, pilot plant, production, and sterile product and solid dosage forms considerations. In the early 1990s, the concept of preapproval inspection (PAI) was born and had as one of its basic tenets the assurance that approved validation protocols and schedules were being generated and that comprehensive development, scale-up, and biobatch and commercial batch validation data were required in order to achieve a successful regulatory PAI audit. There are several important reasons for validating a product and/or process. First, manufacturers are required by law to conform to cGMP regulations. Second, good business dictates that a manufacturer avoids the possibility of rejected or recalled batches. Third, validation helps to ensure product uniformity, reproducibility, and quality. Although the original focus of validation was directed towards prescription drugs, the FDA Modernization Act of 1997 expanded the agency’s authority to inspect establishments manufacturing over-the-counter (OTC) drugs to ensure compliance with cGMP. Once the concept of being able to predict process performance to meet user requirements evolved, FDA regulatory officials established that there was a legal basis for requiring process validation. The ultimate legal authority
is Section 501(a)(2)(B) of the FD&C Act, which states that a drug is deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or were not operated or administrated in conformity with cGMP. The cGMP regulations for finished pharmaceuticals, 21 CFR 210 and 211, were promulgated to enforce the requirements of the act. FDA has the authority and responsibility to inspect and evaluate process validation performed by manufacturers. The cGMP regulations for validating pharmaceutical (drug) manufacturing require that drug products be produced with a high degree of assurance of meeting all the attributes they are intended to possess
1. Prospective Process Validation- Where an
experimental plan called the validation protocol is
executed (following completion of the qualification
trials) before the process is put to commercial use. Most
validation efforts require some degree of prospective
experimentation in order to generate validation support
2. Concurrent Process Validation- Establishing
documented evidence that the process is in a state of
control during the actual implementation of the process.
This is normally performed by conducting in-process
testing and/or monitoring of critical operations during
the manufacture of each production batch.
3. Retrospective Process Validation- Where historic
data taken from the records of the completed
production batches are used to provide documented
evidence that the process has been in a state of control
prior to the request for such evidence[14,15]
PROCESS VALIDATION: AN ESSENTIALITY IN THE PHARMACEUTICAL INDUSTRY
The principal objective of dosage form design is to
achieve a predictable therapeutic response to a drug
included in a formulation which is capable of large scale
manufacture with reproducible product quality. To
ensure product quality, numerous features are
required, like chemical and physical stability, suitable
preservation against microbial contamination if
appropriate, uniformity of dose of drug, acceptability to
users including prescriber and patient, as well as
suitable packing, labeling, and validation[1]
The development of a drug product is a lengthy process
involving drug discovery, laboratory testing, animal
studies, clinical trials and regulatory registration. To
further enhance the effectiveness and safety of the drug
product after approval, many regulatory agencies such
as the United States Food and Drug Administration
(USFDA) also require that the drug product be tested for
its identity, strength, quality, purity and stability before
it can be released for use. For this reason,
pharmaceutical validation and process controls are
important in spite of the problems that may be
encountered[2]
The concept of validation was first proposed by two
Food and Drug Administration (FDA) officials, Ted Byers
and Bud Loftus, in the mid 1970’s in order to improve
the quality of pharmaceuticals. The first validation
activities were focused on the process involved in
making these products but quickly spread to associated
processes involving environmental control, media fill,
equipment sanitization and purified water
production[3,4]
In a guideline, validation is act of demonstrating and
documenting that any procedure, process, and activity
will consistently lead to the expected results. It includes
the qualification of systems and equipment. The goal of
the validation is to ensure that quality is built into the
system at every step, and not just tested for at the end,
as such validation activities will commonly include
training on production material and operating
procedures, training of people involved and monitoring
of the system whilst in production. In general, an entire
process is validated and a particular object within that
process is verified. The regulations also set out an
expectation that the different parts of the production
process are well defined and controlled, such that the
results of that production will not substantially change
over time[5]
NEED OF VALIDATION
1. It would not be feasible to use the equipments
without knowing whether it will produce the
product we wanted or not.
2. The pharmaceutical industry uses expensive
materials, sophisticated facilities & equipments and
3. The efficient use of these resources is necessary for
the continued success of the industry. The cost of
product failures, rejects, reworks, and recalls,
complaints are the significant parts of the total
4. Detailed study and control of the manufacturing
process- validation is necessary if failure to be
reduced and productivity improved.
5. The pharmaceutical industries are concerned about
validation because of the following reasons.
6. Assurance of quality.
7. Cost reduction.
8. Government regulation[6,7]
1. Site validation committee (SVC): Develop site master
validation plan, Prepare/ execute/ approve
2. Manufacturing department: Prepares the batches as
a routine production batch.
3. Quality assurance: Ensure compliance, see that
documentations/ procedures are in place, approves
protocols and reports.
4. Quality control: Perform testing and reviews
protocol and report as needed[7]
RESPONSIBLE AUTHORITIES FOR VALIDATION
The validation working party is convened to define
progress, coordinate and ultimately, approve the entire
effort, including all of the documentation generated.
The working party would usually include the following
staff members, preferably those with a good insight into
the company’s operation.
• Head of quality assurance.
• Head of engineering.
• Validation manager.
• Production manager.
• Specialist validation discipline: all areas
Department /Designation Responsibility
Manager Production Responsible for manufacturing of batches and review of
protocol and report.
Manager QC Responsible for analysis of samples
Executive QC Responsible for samples collection and
submission to QC
Manager Maintenance Providing utilities and engineering
Executive Production Responsible for preparation of protocol and manufacturing of
Manager QA Responsible for protocol authorization and preparation of
ESSENTIALS OF PHARMACEUTICAL VALIDATION
Validation is an integral part of quality assurance; it
involves the systematic study of systems, facilities and
processes aimed at determining whether they perform
their intended functions adequately and consistently as
specified. A validated process is one which has been
demonstrated to provide a high degree of assurance
that uniform batches will be produced that meet the
required specifications and has therefore been formally
approved. Validation in itself does not improve
processes but confirms that the processes have been
properly developed and are under control. Adequate
validation is beneficial to the manufacturer in many
1. It deepens the understanding of processes;
decreases the risk of preventing problems and thus
2. The smooth running of the process.
3. It decreases the risk of defect costs.
4. It decreases the risk of regulatory noncompliance.
5. A fully validated process may require less in-process
controls and end product testing[8,9]
Design Qualification (DQ):-
It is a documented review of the design, at an
appropriate stage of stages in the project, for
conformance to operational and regulator
DQ check items:
1. Goods manufacturing practices and regulator
2. Performance criteria.
3. Facility air flow, movement flow and pressur
4. Reliability and efficiency.
5. Commissioning requirements.
6. Construct ability and installation of equipment.
7. Maintenance and access to critical equipment an
8. Safety and environment impact.
INSTALLATION QUALIFICATION (IQ):-
It is a documented verification that all the aspects of
facility, utility or equipment that can affect produc
quality adhere to approved specifications and ar
Important IQ considerations are:
1. Installation conditions (wiring, utilities an
2. Calibration, preventive maintenance, cleanin
3. Safety features.
4. Supplier documentation, prints, drawings and
5. Software documentation.
6. Spare parts list.
7. Environmental conditions (such as clean room
requirements, temperature and humidity).
8. Equipment design features (i.e. materials of
construction clean ability).
It is a documented verification that all aspects of a
facility, utility or equipment that can affect product
quality operate to intend throughout all anticipated
OQ considerations include:
1. Process control limits (time, temperature, pressure,
line speed and set up conditions).
2. Software parameters.
3. Raw material specifications.
4. Process operating procedures.
5. Material handling requirements.
6. Process change control.
8. Short term stability and capability of the process
(latitude studies or control charts).
9. Potential failure modes, action levels and worst-case
conditions (Failure Mode and effects).
10. Fault tree analysis.
PERFORMACE QUALIFICATION (PQ)
facility, utility or equipment perform as intended in
meeting predetermined acceptance criteria.
PQ considerations include:
1. Actual product and process parameters and
procedures established in OQ.
2. Acceptability of the product.
3. Assurance of process capability as established in OQ.
4. Process repeatability, long term process stability
Major Phases in Validation
The activities relating to validation studies may be
classified into three:
Phase 1: This is the Pre-validation Qualification Phase
which covers all activities relating to product research
and development, formulation pilot batch studies, scale-
up studies, transfer of technology to commercial scale
batches, establishing stability conditions and storage,
and handling of in-process and finished dosage forms,
equipment qualification, installation qualification,
master production document, operational qualification
and process capacity.
Phase 2: This is the Process Validation Phase. It is
designed to verify that all established limits of the
critical process parameter are valid and that satisfactory
products can be produced even under the worst
Phase 3: Known as the Validation Maintenance Phase, it
requires frequent review of all process related
documents, including validation of audit reports, to
assure that there have been no changes, deviations,
failures and modifications to the production process and
that all standard operating procedures (SOPs), including
change control procedures, have been followed. At this
stage, the validation team comprising of individuals
representing all major departments also assures that
there have been no changes/deviations that should
have resulted in requalification and revalidation[11]
careful design and validation of systems and process
controls can establish a high degree of confidence that
all lots or batches produced will meet their intended
specifications. It is assumed that throughout
manufacturing and control, operations are conducted in
accordance with the principle of good manufacturing
practice (GMP) both in general and in specific reference
to sterile product manufacture. The validation steps
recommended in GMP guidelines can be summarized as
1. As a pre-requisite, all studies should be conducted in
accordance with a detailed, pre-established protocol
or series of protocols, which in turn is subject to
formal – change control procedures;
2. Both the personnel conducting the studies and those
running the process being studied should be
appropriately trained and qualified and be suitable
and competent to perform the task assigned to
3. All data generated during the course of studies
should be formally reviewed and certified as
evaluated against pre-determined criteria;
4. Suitable testing facilities, equipment, instruments
and methodology should be available;
5. Suitable clean room facilities should be available in
both the ‘local’ and background environment. There
should be assurance that the clean room
environment as specified is secured through initial
commissioning (qualification) and subsequently
through the implementation of a programme of re-
testing – in-process equipment should be properly
installed, qualified and maintained;
6. When appropriate attention has been paid to the
above, the process, if aseptic, may be validated by
means of “process simulation” studies;
7. The process should be revalidated at intervals; and
8. Comprehensive documentation should be available
to define support and record the overall validation
Protocols should specify the following in detail:
1. The objective and scope of study- There should
already be a definition of purpose;
2. A clear and precise definition of process equipment
system or subsystem, which is to be the subject of
study with details of performance characteristics;
3. Installation and qualification requirement for new
4. Any upgrading requirement for existing equipment
with justification for the change(s) and statement of
qualification requirement;
5. Detailed stepwise statement of actions to be taken
in performing the study (or studies);
6. Assignment of responsibility for performing the
7. Statement on all test methodology to be employed
with a precise statement of the test equipment
and/or materials to be used;
8. Test equipment calibration requirements;
9. References to any relevant standard operating
procedures (SOP);
10. Requirement for the current format of the report on
11. Acceptance criteria against which the success (or
otherwise) of the study is to be evaluated; and
12. The personnel responsible for evaluating and
certifying the acceptability of each stage in the study
and for the final evaluation and certification of the
process as a whole, as measured against the pre-
defined criteria[12]
13. All personnel involved in conducting the studies
should be properly trained and qualified because
they can, and often, have a crucial effect on the
quality of the end product. All information or data
generated as a result of the study protocol should be
evaluated by qualified individuals against protocol
criteria and judged as meeting or failing the
requirements. Written evidence supporting the
evaluation and conclusion should be available. If
such an evaluation shows that protocol criteria have
not been met, the study should be considered as
having failed to demonstrate acceptability and the
reasons should be investigated and documented.
Any failure to follow the procedure as laid down in
the protocol must be considered as potentially
compromising the validity of the study itself and
requires critical evaluation of all the impact on the
study. The final certification of the validation study
should specify the pre-determined acceptance
criteria against which success or failure was
evaluated[11]
Process validation is defined as the collection and
evaluation of data, from the process design stage
throughout production, which establishes scientific
evidence that a process is capable of consistently
delivering quality products. Process validation is a
requirement of current Good Manufacturing Practices
(GMPs) for finished pharmaceuticals (21 CFR 211) and of
the GMP regulations for medical devices (21 CFR 820)
and therefore applies to the manufacture of both drug
products and medical devices. Process validation
involves a series of activities taking place over the
lifecycle of the product and process