Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
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❖ Batch Formula Record
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Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
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Presentation on quality control tests for the secondary packaging materials. Includes the materials used for secondary packaging, ideal properties of the secondary packaging material and various test procedures used for the quality control of the packaging materials.
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Method validation is the process of documenting / proving that an analytical method provides analytical data acceptable for the intended use. A pharmaceutical drug product must meet all its specifications throughout its entire shelf-life. The performance of product characteristics throughout the shelf-life must be tested by analytical method for the product’s chemical, physiochemical, microbiological and biological characteristics. The method of analysis used must be validated. This is required to ensure the product’s safety and efficacy throughout all phases of its shelf-life. 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.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
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Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.
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Components of GMP
GMP Provisions: Under Schedule-T are grouped
Location and surroundings
Factory Premises
Buildings
Water supply
Containers cleaning
Disposal of Waste
Requirements for the sterile products
store
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Space requirement for manufacturing of Unani medicine
Health & Hygiene
Machinery and Equipments
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Documentation and Records
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method Validation.
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Method validation is the process of documenting / proving that an analytical method provides analytical data acceptable for the intended use. A pharmaceutical drug product must meet all its specifications throughout its entire shelf-life. The performance of product characteristics throughout the shelf-life must be tested by analytical method for the product’s chemical, physiochemical, microbiological and biological characteristics. The method of analysis used must be validated. This is required to ensure the product’s safety and efficacy throughout all phases of its shelf-life. 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.
Analytical method validation as per ich and usp shreyas B R
Analytical method validation is a process of documenting/ proving that an analytical method provides analytical data acceptable for the intended use.After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.
Analytical Method Validation is a process that is used to demonstrate the suitability of an analytical method for an intended purpose.Regulations and quality standards that have an impact on analytical laboratories require analytical methods to be validated.
How the modern concept of a lifecycle model, which is based on process validation and described in ICH guidelines Q8, Q9, and Q10, can be applied to analytical procedures.
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General Principles of Analytical Method of Validation.pdf
1. General Principles of Analytical
Method of Validation
Presented by Shobha Kumari (1912081)
B.Pharmacy (6th sem)
G.H.G. Khalsa college of Pharmacy Gurusar Sadhar, Ludhiana
2. Introduction
Validation is the process of establishing documentary evidence
demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of
compliance all stages.
The process of providing the analytical procedure is acceptable or
its intended us.(ICH Q2)
The analytical methods used for analyzing clinical sample should be
validated. Validation is a process of planned and systematic study
to confirm that it is suitable for intendeduse.
Analytical method are used to test and ensure the quality, purity,
potency of drug substance.
Analytical method are followed from official Pharmacopeia or
developed by users.
Validation of analytical procedure is a process in which laboratory
studies are conducted to establish .
3. Need of validate an Analytical method
For assuring the quality of system
For achieving the acceptance of the
product( safe for human use)
Mandatory requirement for registration of
any pharmaceutical product
Mandatory requirement for accreditation
as per ISO guideline
4. Type of analytical procedure to be
Validated
Identification tests (Identification test ensure the
identity of analyte in sample by comparing s property of
sample with standard.)
Quantitative test for impurity content
Limit test for control of impurity
Assay procedure (Quantitativetest of active moiety in
sample of drug substance or product)
5. When should revalidation be done?
✓ Change in the process for synthesis of the drug
substance
✓ Change in composition of finished product
✓ Change in analytical procedure
✓ Transfer of method from one laboratory to other
✓ Changes in major pieces of equipment
instrument.
7. Specificity
It should be conducted during the validation of
identification tests, determination of impurities and the
assay.
It is ability to measure unequivocally the desired analyte in
presence of components such as excipient and impurities
that may also expected to be present.
8. Linearity
It indicates the ability to produce results that are directly proportional to the
concentration of the analyte in sample.
9. Range
The range is derived from the linearity studies
and depend on intended application of
procedure.
It is interval between the upper and lower
concentration (amount) of analyte in the
sample for which it has been demonstrated that
the analytical procedure has been suitable level
of precision, accuracy and linearity.
10. Accuracy
It is analytical method is the closeness of
test results obtained by that method to
the true value.
Determination: Accuracy should be
established across the specified range of
the analytical procedure.
Assay (drug substance, drug products)
Impurities (Quantitative)
11. Precision
The precision of an analytical procedure expresses
the Closeness of agreement between a series of
measurements obtained from multiple sampling of
same homogenous sample under prescribed
conditions.
12. Robustness
It should be evaluated during the development phase
and evaluation process depend on the type of
procedure being studied. The result from the separate
samples are influenced by changes in operational and
environment conditions (temperatures, pH). It shows
reliability of analysis when deliberate variations are
made in method parameters.
Some example of typical variations in liquid
chromatography include:
✓ Influence of variations of pH in mobile phase
✓ Influence of variations in mobile phase composition
✓ Temperatures
✓ Different columns
13. LOD( limit of detection) :
It is the smallest quantity of an
analytes that can be detected.
Quantitative limits
It is lowest concentration of an analyte in a
simple that may be determined with
acceptable accuracy and precision.
14. System suitability
testing
Integral part of many analytical procedure.
Based on the concept that:
✓ The equipment, electronics, analytical operations
and sample to be analyses constitute an integral
system that can be evaluated as such.
✓ Depends on the type of procedure being
evaluated.
Example: resolution test for an HPLC procedure
