This document discusses pharmaceutical validation which covers every aspect of pharmaceutical processing. It defines validation and describes key areas of validation including analytical methods, equipment, facilities, materials, manufacturing operations, product design, and cleaning. The document outlines different types of validation based on when they are performed in the production process. It also discusses the qualification of facilities, equipment, and services which includes design, installation, operational, and performance qualification. The goals and requirements of validation are also mentioned.

2.  “ Validation can be defined as a procedure that
demonstrates that a process under standard
conditions is capable of consistently producing a
product that meets the established product
specification”.
 “ Validation may be defined as a systematic study
which helps to prove that the systems and process
perform their job adequately & consistent by as
specified”.

3. Pharmaceutical validation is a vast area of
work & it practically covers every aspect
of pharmaceutical processing activity.
However it will point out at least the
following areas of for pharmaceutical
validation.
 Analytical
 Instrument callibration
 Process utility services

4.  Raw material & packaging material
 Equipments
 Manufacturing operation
 Facilities
 Product design
 Cleaning
 Operator

5.  Enable scientist to communicates scientifically &
effectively on technical matter.
 Cost saving, reducing testing , & elimination of
product retesting.
 Useful for comparison of results compliance to
cGMP/GLP.
 For addressing analytical problem to proper form.
 Assurance of Quality
 Safety

6.  Depending on time when it is performed relative
to production it can be classified as:-
1. PROCESS VALIDATION
2. EQUIPMENT VALIDATION
3. CLEANING VALIDATION
4. PERSONNEL VALIDATION
5. ANALYTICAL VALIDATION

7.  The USFDA in guidelines on validation has
offered this definition:-
“Process validation is established documented
evidence which provides a high degree of
assurance that specific process will constantly
produce a product meeting its predetermined
specification & quality characteristics”.

8. a) Prospective Validation.
b) Retrospective Validation.
c) Concurrent Validation.
d) Revalidation

9.  This is employed when historical data of the product
is not available or is not sufficient & in process &
furnished product testing are not adequate to ensure
reproducibility.
 Such validation is conducted prior to release of
either new product or product made under revised /
new manufacturing process.

10.  This provide trend of comparative results i.e. review
& evaluation of existing information for comparison
when historical data is sufficient & readily available.
 This method is chosen when Prospective validation
can not be justified for economic consideration &
resource limitation.

11.  Based on information generated during
implementation of a system.
 For this extensive testing & monitoring are
performed as part of running of the method.
 This validation verifies the quality characteristic
of a particular batch & provide assurance.

12.  Whenever there is a change in formulation
,equipment or process which could have impact
on product effectiveness or product
characteristics.

13.  The validation of facilities equipment & services
is called ‘ Qualification’ this is divided into:-
 a) Design Qualification.
 b) Installation Qualification.
 c) Operational Qualification.
 d) Performance Qualification.

14.  Prior to install a machine or equipment it
is performed.
It include
 The size or volume of the machine.
 How it would be.

15.  Introduction & objective.
 Identification of information.
 Purpose of facility or equipment.
 Construction details.
 Details services required & provides.
 Acceptance level.

16.  The OQ process ensure that the specific
modules of the system are operating
according to the defined specification for
accuracy, linearity & precision.

17.  It include:-
 Identification, objective & identification
information.
 Visual inspection.
 Functioning of switches & indicator lights.
 Check & calibration of sensor, airflow rate &
pressure etc.
 Cleaning procedure.

18.  PQ testing is conducted under actual
running condition across the whole
working range.
 Once IQ & OQ have been executed &
and have been approved then the PC
can be performed.
 It include various performance
parameter of any instrument.

19.  Objective is to minimize the cross
contamination.
 Three sampling methods are generally
used.
(i) Solvent rinse.
(ii)Swab technique.
(iii)Placebo rinse method

20. This is related to individual quality & health
condition
o Grouping Validation.
o Medical Examination.
o Personnel concerned are trained.

21. Refers to the evaluation & proving that an
analytical method serves the intended
purpose.
It can be classified into Three types
 Personnel ( analyst)
 Equipment & facilities
 Procedure (adopted for analyzing a
drug.

22.  Specificity
 Accuracy
 Repeatability
 Reproducibility
 Detection Limit
 Quantification Limit
 Sensitivity
 Range