m pharmacy notes

1. A seminar on
PROCESS VALIDATION OF CAPSULE
BY
SALUNKHE NIKHIL JAYVANTRAO
UNDER THE GUAIDANCE OF
Dr. S. G. SUDKE

2. CONTENT
1. Introduction
2. Reasons for validation
3. Types of process validation
4. Validation of capsule

3. DEFINATION
 “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.

4. INTRODUCTION
 Validation is one of the important steps in achieving
and maintaining the quality of the final product.
 If each step of production process is validated we can
assure that the final product is of the best quality.
 Validation of the individual steps of the processes is called
the process validation. Different dosage forms have
different validation protocols.
 Here this seminar concentrates on the process validation of
capsule dosage forms.
 It gives in detail the validation of each step of the
 manufacturing process of capsule dosage forms.

5.  Quality assurance:
Validation checks the accuracy and
reliability of a system or a process to meet the predetermined
criteria.
•A successful validation provides high degree of assurance
that a consistent level of quality is maintained in each unit
of the finished product from one batch to another batch.

Reasons for validation:-

6.  Economics: Due to successful validation, there
is a decrease in sampling and testing
procedures and there are less number of
product rejections and retesting. This leads to
cost-saving benefits.
 Compliance: For compliance to current good
manufacturing practices, validation is
essential.

7. TYPES OF PROCESS
VALIDATION
7
PROCESS
VALIDATION
RETROSPECTIVE
PROCESS
VALIDATION
PROSPECTIVE
PROCESS
VALIDATION
CONCRURRENT
PROCESS
VALIDATION

8. Types Of Process Validation
 Prospective validation: -
Conducted prior to market the product.
 Documented evidence which provides a high degree of
assurances that a specific process or equipment will consistently
produce a product meeting its predetermined specifications and
quality attributes.


9.  Concurrent validation:
Based on information generated during
actual implementation of the process.
 Establishing documented evidence
that the process is in a state of control
during the actual implementation of the
process. This normally performed by
conducing in- process testing.

10.  Retrospective validation:
All the processes and subsystems should be
validated,
which have been used for the production of batches of
numerical data of both process and the end product
testing of which are included in retrospective validation

11. PRODUCT VALIDATION
 Product validation involves following steps:
 Validation of raw materials and excipients.
 Analytical methods of validation.
 Equipment and facility validation .
 Process variables and limits.

12. VALIDATION OF RAW MATERIALS AND
EXCIPIENTS
 The validation process of solid dosage form begins with the
validation of raw materials , both API and excipients.
 Preformulation is one of the critical step to be validated in
product validation
 Physical characters such as drug and particle size can
affect material flow and blend uniformity.
 Chemical characters like impurities can effect stability of
drug.
 The hygroscopic nature is important in both handling and
reproducibility of the manufacturing process.

13. ANALYTICALMETHODS OF
VALIDATION-
 Accuracy of method: Ability of a method to
measure the true value of a sample.
 Precision of method: Ability of a method to
estimate reproducibility of any given value.
 Specificity: Ability to accurately measurethe
analyte in the presence of other components.
 Repeatability: Does the precision and
accuracy of the method change when
conducted numerous times on the same day
and repeated on a subsequent day?

14.  Reproducibility: Repeat the precision and
accuracy studies within the same lab using the
same instrument but different analysts to
challenge the reproducibility of the method.
 Precision: How will different instruments
within the same lab run by the same analyst
affect the accuracy and precision of the
method.
 Ruggedness: Will the precision and accuracy
of the method be same between the
development and quality control lab

15. EQUIPMENT VALIDATION
 This can be divided into
1. Design qualification
2. Installation qualification
3. Operation qualification
4. Performance qualification
5. Maintaince (calibration, cleaning, repair) qualification

16.  Design qualification (DQ): Documented
verification of the design of equipment and
manufacturing facilities.
 Installation qualification (IQ): Documented
verification of the system design and adherence
to manufacturer’s recommendations.
 Operational qualification (OQ): Documented
verification of equipment or system
performance in the target operating range.
Documented verification of the
equipment system operates as expected
under routine production conditions.
Process performance qualification (PQ):

17. EQUIPMENT VALIDATION
Design and
development of
equipment system,
or product
Installation
qualification
Operational
qualification
Process
performance
qualification
Change control

19. CAPSULE COMPOSITION-
 Capsule shell provide :
 The reason for the presence of each ingredient in the
capsule formulae.
 Justify the level and grade of each ingredient .
 Explain the selection of the capsule size and shape
 Discuss the need for capsule identification(color).

20. Capsule shell contents-
 Establish the compatibility of the capsule shell and the
capsule contents.
 Determine the hygroscopic nature of the capsule
formulation
For example : A hygroscopicformulation(API
/excipients)can pull water from the capsule shell, which
could effect the API stability.

21. PROCESS EVALUATION
 The process to manufacture the contents of
a hard gelatin capsule is the same as the
tablet.
 It may required only a blending step, such as
a direct compression or several unit
operations (e.g. mixing, wet milling, drying,
dry milling and blending).
 In either case, the materials are
then encapsulated in a capsule
shell.

22. QUALITY CONTROLTESTS
ARE DIVIDED INTO
 PHYSICALTEST
• Disintegration test
• Weight variation
 CHEMICALTEST
• Dissolution test
• Assay
• Content uniformity
• Stability testing Moisture permeation test

23. REFERENCES
1. http//www.pharmainfo.net/reviews/guidelines-general-
principles-validation-solid-dosage.
2. www.google.com
3. www.fda.gov/cder/guidance/pv.html

24. Thank you