This document discusses calibration and qualification. It begins by defining calibration as comparing a measurement system or device of unknown accuracy to a standard of known accuracy. The objectives of calibration are to check accuracy, determine traceability, and provide confidence that results meet specifications. Calibration is important to detect drift over time and ensure measurements remain reliable. Qualification establishes that equipment is suitable for its intended use and performs properly. It includes design qualification to define specifications, installation qualification to confirm proper installation, operational qualification to demonstrate functional specifications are met, and performance qualification to establish consistent performance.
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
A validation programme involves various components in pharmaceutical organisation related to process, equipment and product.
It is a regulatory requirement for pharmaceutical companies to perform Instrument Validation on all new instruments.
Instrument Validation requires detailed knowledge of the instrumentation system being validated and is therefore usually performed by the company supplying the instrument.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Definition
Scope of calibration
Scope of validation
Frequency of calibration
Importance/ purpose of calibration
Importance/ advantages of validation
Difference between calibration & validation
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
A validation programme involves various components in pharmaceutical organisation related to process, equipment and product.
It is a regulatory requirement for pharmaceutical companies to perform Instrument Validation on all new instruments.
Instrument Validation requires detailed knowledge of the instrumentation system being validated and is therefore usually performed by the company supplying the instrument.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Definition
Scope of calibration
Scope of validation
Frequency of calibration
Importance/ purpose of calibration
Importance/ advantages of validation
Difference between calibration & validation
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
NCQC is sharing information about Instrument Calibration and its requirements in organizations. This ppt presentation helps organization and management trainee to understand purpose, importance and requirements of calibration management system.
1- Lead the Over all Calibration Program from Preparation of Annual Calibration Schedule , Coordination with outsource service providers, Plan and Execute the Calibration exercise as per Annual Calibration Plan
2- Prepare Validation Master Plan by coordination with Production, Planning, Engineering ,Research & Development & Quality Assurance Departments as per WHO and PIC/S guidelines.
3- Execution of Process Validation activities as per approved Validation Master Plan by preparing Protocols and implementing validation activities, Reviewing results and finalize the reports accordingly.
4-Prepare protocols for equipment qualification, facility, system and process validation as per the approved annual validation plan for following areas:-
a. Solid
b. Liquid
c. Cream
d. Hormone
e. Lyophilization
f. Eye Drops
g. Cephalosporin
5-Monitor activities of following validation as per approved Protocols, SOPs & Validation Master Schedule (VMS):-
a. Equipment Qualification
b. System Qualification
c. Computer System Validation
d. URS, DQ, IQ, OQ, PQ
e. Other Validation as per cGMP requirement
6-Prepare Aseptic process Simulation (MFT) protocol, Report & BMR as per International guidelines, plan & executed MFT in Sterile area
Pharmaceutical Instrument and Analytical Validation and Qualification (SHOPNI...ShopnilAkash5
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages
It is essential to ensure the quality Of a product and Good Manufacturing Practices including all other regulatory requirements
Introduction of Validation and Calibration. Definition of Validation and Calibration. Qualification and Validation. Scope and importance
Difference between Calibration and Validation
Validation.
Validation is establishing documented evidence which provides a high degree of assurances that a specific process or equipment will consistently produce a product or result meeting its predetermined specifications and quality attributes”.
A system must be qualified to operate in a validated process
The results of analytical procedures should be:
— reliable
— accurate
— reproducible
The characteristics that should be considered during validation of analytical methods are:
— specificity
— linearity
— range
— accuracy
— precision
— detection limit
— quantitation limit
— robustness
Liquid preparations having two phases are termed as
biphasic liquids.
DEFINITION, ADVANTAGES AND
DISADVANTAGES, CLASSIFICATIONS,
PREPARATION OF SUSPENSIONS;
FLOCCULATED AND
DEFLOCCULATED SUSPENSION &
STABILITY PROBLEMS AND METHODS
TO OVERCOME
Emulsion
Definition, classification, emulsifying
agent, test for the identification of
type of Emulsion, Methods of
preparation & stability problems and
methods to overcome.
A medical prescription (℞) is an order (often in written form) issued by a
qualified health care professional (e.g. physician and dentist) to a pharmacist or
other therapist for a treatment (medicine or device) to be provided to their patient.
1.INTRODUCTION OF PRESCRIPTION
2.PARTS OF PRESCRIPTION
3.TYPES OF PRESCRIPTION
4.LEGAL REQUIREMENT FOR VALID PRESCRIPTION
5.HANDLING OF PRESCRIPTION
6.ERROR IN PRESCRIPTION
7.ABRIVIATIONS
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
Description of Effluent treatment plant ,its process,types of waste water discharge , Regulations And Guideline Overview , Designing of ETP , special test for tretment of water , etc
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
2. CALIBRATION
“comparison of measurement system or device of unknown
accuracy to another measurement system or device of known
accuracy to detect, correlate report or eliminate by adjustment
any variation from required performance limits of unverified
measurement system or device ”
To maintain the accuracy and precision of test equipment at all
times. To ensure highest level of confidence in all measurement
that affect materials disposition decision, with unbroken chain of
traceability to national standard.
To determine whether the equipment is still fit for its intended
purpose.
This is important for justifying the processes of Qualification and
Validation.
2
3. Objectives
It checks the accuracy of an instrument
It determines the traceability of the measurement
provides confidence that your products /services /
results meet their specifications .
4. Purpose /Need Of Calibration
Components age and equipment undergoes changes in
temperature or humidity or sustains mechanical stress,
performance degrades. This is called drift. Then test results
become unreliable. While drift cannot be eliminated, it can be
detected and either unreliable. While drift cannot be
eliminated, it can be detected and either corrected or
compensated for through the process of calibration.
Properly calibrated equipment provides confidence that your
products/services/results meet their specifications .
Calibration: Optimizes resources; Ensures consistency; and
Ensures measurements (and perhaps products) are compatible
with those made elsewhere.
By making sure that your measurements are based on
international standards, you promote acceptance of your
products/services/results .
5. conti...
Master Instrument List -
Description or name
Unique identifier
Instrument accuracy, range, etc.
Calibration frequency
Location
Expiration or due date
Applicable calibration procedure and standards.
6. Scope Of Calibration
6
To make sure that the readings of equipment or instruments are
consistent with other measurements and display the correct
readings every single time.
To determine the accuracy, precision, reliability and deviation of
the measurements produced by all the instruments.
To establish the reliability of the instrument being used and
whether it can be trusted to deliver repeatable results each time.
To map the ‘drift’ as documented. Instruments have a tendency to
produce inaccurate measurements over a period of time,
following repeated use.
Ensuring that the industry standards, quality assurance
benchmarks such as cGMP and government regulations are
adhered to.
7. Advantages Of Calibration
The knowledge of the nature and extent of errors of the
testing and measuring the instruments employed in quality
measuring system, will help an organization in the
following ways:
One can take the error of an instrument into account while
using it and hence correct measurements are recorded and
reported .this will help an organization to set its process and
quality control system correctly.
Wherever possible, one can adjust or repair the instrument
to minimize the error to the best extent.
Any dispute arising with a customer due to instrument
error can be resolved.
8. Quality Critical Equipment
Those items of equipment necessary to perform a testand
which have a significanteffect on the uncertainty
ofmeasurement of test results.
The laboratory shall furnishequipment needed to perform
Quality Critical Testing for:
Sampling
Measurement
Processing
Analyzing test data
9. Equipment & Software
Capable of achieving accuracy
Complies with specifications elevant to tests
Calibrated & checked prior to placing into service
Meets specification requirements
Complies with standard specifications
Records must be kept
10. Equipment Needs & Documentation
All measurement and testing equipment have a significant
effect on the validity and accuracy of test results
All equipment that requires calibration shall be labelled,
coded, or otherwise identified to indicate the status of
calibration, including the last date of calibration and date of
expiration or due date of next calibration.
Equipment sent out of the laboratory must be recalibrated or
checked and shown to be satisfactory before placing into
service.
Calibration and verification takes place at specified intervals
through the use of traceable standards or appropriate reference
materials or reference cultures.
12. EQUIPMENT CLASSIFICATION
Critical equipment:
Direct measurement that affect the final product quality.
Measurement on critical process parameters in the
process specification.
Non critical equipment:
Indirect measurement that will not directly affect the
final product quality.
Shall be maintained based on company maintenance
schedule.
13. CALIBRATION INTERVAL
Depending on:
Classification of Critical or non-critical
Usage (light or heavy usage)
Handling (light or heavy handling) Handling (light or
heavy handling)
Manufacturer’s recommendation
Reference to NIST or accreditation body guideline for a
specific measurement system
14. Frequency Of Instrument Calibration
14
How often you conduct instrument calibration mainly depends
upon its tendency to drift from the true measurement and how it
impacts the quality of the end product. Examine each instrument
being used and study its behavior. Based on this information, you
can design a calibration schedule for each instrument.
The interval between calibrations can vary as:
Weekly
Monthly or bi-monthly
Quarterly, semi-annually or annually
After every heavy usage of the instrument
15. When Should The Measuring Instruments Be Calibrated?
15
The frequency of calibrating the measuring instruments depends
on a number of different factors. The following is a guide
outlining when instruments need to be calibrated as a part of
GMP:
As soon as you bring in a new instrument, you should calibrate
it before you test it out.
Before and after you take critical measurements
After any instance of electrical or mechanical shock or a
similar event that includes a fall, bump, etc.
When you suspect that the accuracy of measurements
being produced is questionable
If there were any repairs or re-qualifications of the instrument
As per included as part of a calibration schedule
Depending on the task and processes as some require
calibration to be conducted before the work starts
According to the manufacturer’s recommendation
16. Measurement Traceability & Equipment
All measurement and testing equipment that has a significant
effecton the validity and accuracy of test results should be
calibrated or verified at specified intervals through the use of
traceable standards
or appropriate reference materials
Traceability applies to measuring and test equipment unless
youcan prove that it is a minor component of measuring
uncertainty. In this case, you must provide the uncertainty of
the instrument.
17. Support Equipment That Require Calibration
Not test equipment, but includes:
Balances
Ovens
Refrigerators
Freezers
Incubators
Water baths
Temperature measuring devices
Thermal/pressure sample preparation devices
Volumetric dispensing devices (including automatic dilutor /
dispensing devices)
If quantitative results are dependent on their accuracy
19. “ Do you think that we can
performproper calibration in
our Laboratory??? ”
20. CALIBRATION PROCESS
There are different ways that are used to calibrate an instrument
.These methods are chosen based on the desired results of the
calibration and regulatory authorities’ requirements.
The purpose of calibration is to ensure that the measuring
accuracy is known over the whole measurement range under
specified environmental conditions for measurement range
under specified environmental conditions for calibration.
Calibration process must be managed and executed in a
professional manner.
21. Conti...
A particular place for all calibration operations to take place
and keeping all instruments for calibration.
A separate room is preferred because (A) better environmental
control and (B) better protection against unauthorized
handling or use of the calibration instruments.
The performance of all calibration operations is assigned as
the clear responsibility of just one person.
Calibration procedures, used for quality control functions, are
controlled by the international standard ISO 9000. It requires
that all persons using calibration equipment be adequately
trained.
22. Standard Calibration: This method is mostly preferred for calibrating
instruments that are non-critical to quality or are not required for accreditation
and license purposes. Use traceable standards and document its performance.
Calibration with Data: Procedures for calibrations with data are similar to
that of accredited calibration. The only exception being that these procedures
are not accredited to the ISO standard. Moreover, they are not accompanied
by data on measurement uncertainties.
ISO 17025 Accredited Calibration: This has to be the strictest method of
calibration. Generally, it requires a measurement report which has the details
of the measurements that are made against a standard of ‘as found’ (before
calibration is started) and ‘as left’ (once the calibration is completed). If the
calibration is done by a calibration service provider, they must issue a
certificate of the same.
22
Commonly Used Calibration Methods and Procedures
23. PRIMARY STANDARD
Highest accuracy order in the measurement system.
Traceable to National or International standard.
24. REFERENCE STANDARD & MATERIAL
Reference Standard
It shall be calibrated by a body that can provide traceability.
Such reference standard of measurement held by the laboratory
shall be used for calibration only. It shall be calibrated before
and after any adjustment.
Reference Materials
Where possible, it shall be traceable to SI units of measurement,
or toCertified Reference Materials. Internal Reference Material
shall be checked as far as is technically and economically
practical.
25. Importance of Regular Calibration
11
Calibration is responsible for defining the accuracy of any
measurement and its quality that is recorded by any instrument.
When you start working with any instrument, it must be calibrated
well, thus assuring you of accurate results. However, over a
period of time you will start observing a ‘drift’. Calibration
minimizes such uncertainties by assuring the accuracy of the test
equipment.
When you regularly calibrate your equipment, you can eliminate
the drift at its budding stage instead of allowing it to grow till it
affects the measurements in significant ways.
Calibration helps in quantifying and controlling errors and
uncertainties within various measurement processes to an
acceptable level.
Further, it helps in improving the accuracy of the measuring
device, which in turn improves the quality of the end product.
In short, regular calibration allows pharmaceutical companies to
have confidence in their results which they can record, monitor
and control.
26. CALIBRATION IDENTIFICATION
Status of equipment calibration shall be available and affixed
to the equipment where applicable.
Equipment identification shall bear the following information:
Name of equipment name of equipment
Serial no.
Date calibrated
Status
Schedule of next calibration and
Initial/Signature of the person who performed the
calibration
27. OUT OF CALIBRATION
Remove equipment from use.
Out of Calibration Investigation to be carried out to
determine the source of inaccuracy.
Evaluate the impact of OOC result on the final product
quality and other previously measured data.
All investigation findings should be documented.
28. CALIBRATION RECORDS
Calibration include the control of all critical measurement
equipment that contain the following details:
Name
Identification by model and serial
Location
Owner/Responsible
Calibration Frequency
Calibration due date
Calibration Certificate
Calibration Procedure
29. CALIBRATION CERTIFICATE
Name and address of contracted calibration laboratory.
Name and address of client.
Description and identification of item calibrated.
Environment conditions when calibration was made.
Date of receipt of instrument, date of calibration and date of
next calibration.
Calibration method.
Result of calibration.
Signature and title of person responsible for the calibration.
External calibration contract shall be awarded to Accredited
by the nation institution.
30. QUALIFICATION
30
It refers to activities undertaken to demonstrate that utilities and
equipment are suitable for their intended use and perform
properly.
It is the action of proving that any equipment or process works
correctly and consistently and produces the expected results.
“It is the action of proving and documenting that equipment or
ancillary systems are properly installed, work correctly, and
actually lead to the expected results.”
Qualification is part of validation, but the individual
qualification steps alone do not constitute process
validation.
31. Qualification of analytical instrumentation is essential for
accurate and precise measurement of analytical data. If the
instrumentation is not qualified, ensuring that the results
indicated are trustworthy, all other work based upon the use of
that instrumentation is suspect.
Qualification of instruments is not a single, continuous process
but instead results from many discrete activities. For
convenience, these activities have been grouped into 4 phases of
qualification. These phases are described below
Design Qualification (DQ)
Installation Qualification ( IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
31
32. DESIGN QUALIFICATION
Design qualification (DQ) defines the functional and
operational specifications of the instrument and details
for the conscious decisions in the selection of the
supplier
33. Points to be considered for inclusion in a DQ
Description of the analysis problem
Description of the intended use of the equipment
Description of the intended environment
Preliminary selection of the functional and
performance specifications (technical, environmental,
safety)
34. DQ check items
GMPs and regulatory requirements
Performance criteria
Reliability and efficiency
Commissioning requirements
Construct ability and installation of equipment
Safety and environment impact
Description of the intended use of the equipment
Preliminary selection of the supplier
Final selection of the equipment
34
35. INSTALLATION QUALIFICATION
Installation qualification establishes that the instrument
is received as designed and specified, that it is properly
installed in the selected environment, and that this
environment is suitable for the operation and use of the
instrument
36. Equipment design features (i.e. material of construction
cleanability, etc.)
Installation conditions (wiring, utility, functionality, etc.)
Calibration, preventative maintenance, cleaning schedules.
Safety features.
Supplier documentation, prints, drawings and manuals.
Software documented.
Spare parts list.
Environmental conditions (such as clean room
requirements, temperature, and humidity).
Any problems identified in I.Q must be investigated and
appropriate actions must be taken. All such actions must be
documented and approved by higher authority.
36
IQ check items
38. Process control limits (time, temperature, pressure, line speed,
setup conditions, etc.)
Software parameters.
Raw material specifications
Process operating procedures.
Material handling requirements.
Process change control.
Training.
Potential failure modes, action levels and worst-case
conditions.
The use of statistically valid techniques such as screening
experiments to optimize the process can be used during this
phase.
Any problems identified in O.Q must be investigated and
appropriate actions must be taken. All such actions must be
documented and approved by higher authority.
38
OQ check items
40. Conti...
PQ considerations include:
Actual product and process parameters and procedures established in
OQ.
Acceptability of the product.
Assurance of process capability as established in OQ.
Process repeatability, long term process stability.
It is used to establish and or confirm-
Definition of performance criteria and test procedures.
Selection of critical parameters, with predefined specifications.
Determination of the test intervals, e.g.,
Everyday.
Every time the system is used.
Before, between and after a series of runs.
Define corrective actions on what to do if the system does not meet
the established criteria.
41. Modification to, or relocation of equipment should follow
satisfactory review and authorization of the documented change
proposal through the change control procedure. This formal
review should include consideration of re-qualification of the
equipment.
Minor changes or changes having no direct impact on final or in-
process product quality should be handled through the
documentation system of the preventive maintenance program.
41
Re – Qualification
42. Calibration and maintenance procedure (SOP)
There should be a documented SOP for conducting
the calibration and preventive maintenance for
each type of instrumentation.
The SOP for calibration must includes accuracy and
precision limits and what are the remedial actions should
be taken if this limits do not meet with each other. There
should be an authorized department to perform and
monitor calibration and maintenance.
The SOP must contain the step by step calibration
instructions, instrumentation manual, proper calibration
procedures, provisions for adjustments, provisions for
record and document the actual measurement reading
before and after doing adjustment.
43. REFERENCES
Quality Assurance guid by organization of
pharmaceutical producer of india.
FJ Caeleton , J Agalloco , validation of pharmaceutical
process, Marcel Dekker Inc.
M.A Podar,Pharmaceutical Quality Assurance, nirali
prakashan , pune
Guideline on ASEAN Cosmetic GMP (2003)
WHO Guideline For Sampling OF Pharmaceuticals and
related materials