STANDARD OPERATING PROCEDURE Page 1 of 14

PROCESS VALIDATION
SOP No. QAD/SOP/017/02 SUPERSEDED No. QAD/SOP/017/01
EFFECTIVE DATE TO BE REVIEWED ON
DEPARTMENT QUALITY ASSURANCE

1.0 OBJECTIVE:
This Standard Operating Procedure is intended to provide the science and risk based process
validation life cycle approach for collection and evaluation of data from the process design stage
through commercial production that establishes scientific evidence that a process is capable of
consistently delivering quality product during routine commercial production.

2.0 SCOPE:
2.1 This Standard Operating Procedure is applicable to process performance qualification (Stage-II)
and continued process verification (Stage-III) of drug products manufactured at M/s Brassica
pharma pvt Limited,.

3.0 RESPONSIBILITIES:
3.1 Quality Assurance (QAD):
3.1.1 Preparation of Process Validation Protocols and Reports.
3.1.2 To perform sampling as mentioned in Process validation protocol.
3.1.3 To monitor the Process validation activity.
3.1.4 To provide Protocol base training on process validation protocol to concerned personnel
before execution of the Validation activity (whenever required).
3.1.5 Investigation of deviation, OOS or failures if any.
3.2 Formulation Research Development (FRD):
3.2.1 Carry out Process Design (Stage-I).
3.2.2 Head/ Designee Review Process validation protocol and report.
3.2.3 To monitor the Process validation activity.
3.2.4 To provide information related to Critical Process Parameter, Critical Quality Attributes
and technical support during validation activity.
3.2.5 To support for Investigation of deviation, OOS, or failures if any.

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3.3 Production (PRD):

3.3.1 Head/ Designee Review Process validation protocol and report.
3.3.2 Execution of process validation as per the approved protocol, BMR.
3.3.3 To ensure all the equipment are in qualified and validated state prior to execution of batch.
3.3.4 To initiate the Manufacturing investigation in case of failure during validation study.
3.3.5 Reporting of deviation and non-conformances.
3.4 Quality Control (QCD):
3.4.1 Head/ Designee review process validation protocol and report.
3.4.2 To analyze all the validation samples as per protocol or tests mentioned in the test request
form.
3.4.3 To ensure all the instruments are in qualified state.
3.4.4 To ensure the availability of specification, test method prior to analysis.
3.4.5 To initiate the investigation in case of failure during analysis.
3.5 Engineering (ENG):
3.5.1 Head/ Designee review process validation protocol and report.
3.5.2 To provide support during process validation.
3.5.3 To ensure preventive maintenance of equipments prior to use.
3.5.4 To support for Investigation of deviation, OOS, or failures if any.
3.6 QAD Head/Designee:
3.6.1 To ensure the compliance of the procedure.
3.6.2 To review and approve Process validation protocol and reports.
3.6.3 Investigation of deviation, OOS or failures if any.
3.7 Customer/Contract giver: Review and approval of the protocol (If applicable)

4.0 DOCUMENT REFERENCES:

4.1 SOP on SOP (QAD/SOP/001)
4.2 US FDA guideline for process validation general principles and Practices (January-2011 “Current
Good manufacturing practices”, Revision-1).

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4.3 EMEA guideline on Process validation for finished products

EMA(CHMP/CVMP/QWP/BWP/70278/2012-Rev1).
4.4 Eudralex Volume 4, Annex-15 Qualification and Validation.
4.5 Supplementary guideline on WHO GMP-validation; Appendix 7: Non Sterile Process validation.
4.6 Change control system (QAD/SOP/005).
4.7 Handing of Deviation (QAD/SOP/009).
4.8 Continued process verification (QAD/SOP/048).
4.9 Handing of out of specification (QAD/SOP/025).

5.0 PROCEDURE:
5.1 Definitions:
5.1.1 Process Validation: Process validation is defined as the collection and evaluation of
data, from the process design stage through commercial production, which establishes
scientific evidence that a process is capable of consistently delivering quality product.
5.1.2 Process Design: Defining the commercial manufacturing process based on knowledge
gained through development and scale-up activities.
5.1.3 Process Qualification: Confirming that the manufacturing process as designed is
capable of reproducible commercial manufacturing.
5.1.4 Capability of a Process: Ability of a process to produce a product that shall fulfil the
requirements of that product.
5.1.5 Performance Indicators: Measurable values used to quantify quality objectives to
reflect the performance of an organization, process system.
5.1.6 Concurrent Release: Releasing for distribution a Batch/lot of finished product,
manufactured following a qualification protocol, that meets the Batch/lot release criteria
established in the protocol, but before the entire study protocol has been executed.
5.1.7 Quality: The degree to which a set of inherent properties of a product, system or process
fulfills requirements.

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5.1.8 Critical Process Parameter (CPP): A process parameter whose variability has an
impact on a critical quality attribute and therefore to be monitored and controlled to
ensure the process produces desired quality
5.1.9 Critical Quality Attribute (CQA): A physical, chemical, biological, or microbiological
property or characteristic that should be within an appropriate limit, range or distribution
to ensure desired product Quality.
5.1.10 Continued Process Verification: An approach in which manufacturing process
performance is continuously monitored and evaluated.
5.1.11 Exhibit Batch: Exhibit batches which are taken in GMP approved facility, to generate
manufacturing analytical and stability data required for regulatory filling in countries
such as USA, UK and other countries based on regulatory requirements.
5.1.12 Sampling plan: A specific plan that describes where (locations/time intervals) and how
the samples to be taken from the batch and the number of samples taken from each
location.

5.2 Process Validation Approach and Methodology:

5.3.1 The number of batches included in the process validation and the measurements
performed must be sufficient to allow the normal extent of variation and trends to be
established and to provide sufficient data for evaluation. Three identical batches shall be
considered for process validation. However, if in case of a given drug product multiple
batch sizes or strengths are used, a matrix or bracketing scheme shall be developed that
would result in less than three batches. The selection and use of such a scheme shall be
based on sound technical rationale. As a base line three batches shall be consider for
Process validation.
5.3.2 For site transfer products, the manufacturing process and controls must comply with the
marketing authorization.
5.3.3 Any new product introduced at site shall undergo process validation.

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5.3.4 Each Process validation must comply with local regulatory requirements, customer
requirement and export country regulatory requirements and confirm to the principles
identified within those guidelines.
5.3.5 CPPs and CQAs shall be identified based on the development data/process knowledge.
The acceptance criteria shall be documented in the process validation protocol and the
results of same shall be concluded in the report.
5.3.6 The process validation batches shall be closely monitored by responsible personnel of
FRD, PRD, Quality Assurance team and the data obtained shall be reviewed to assess if it
meets the “Acceptance Criteria”.
5.3.7 If a batch failed during the course of validation, Investigation shall be initiated to find out
the assignable cause for failure. Based on the investigation and assessment, number of
batches shall be decided for further Validation.
5.3.8 In case a product is validated earlier in a set of equipment with specific batch size,
manufacturing formula and process, the same product is manufactured in other area
having like to like set of equipment. Process validation is not applicable based on
equivalency report/assessment/Justification.
5.3.9 Overall sequence of process validation, involves series of activities taking pale during the
life cycle of product which is depicted in Annexure-I

5.3 Process Design:

5.4.1 This shall be based on scientific knowledge gained during laboratory scale and pilot scale
manufacturing. Source of variability and their impact on the product quality shall be
evaluated. The objective of process design is to define and control manufacturing process
such that the sources of variability do not have any negative impact on safety and quality
of the products.
5.4.2 Process design is the activity of defining the commercial manufacturing process which
shall be reflected in Batch Manufacturing Record (BMR). The goal of this stage is to
design a process suitable for routine commercial manufacturing that can consistently
deliver a product that meets its quality attributes.

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5.4.3 Process design experiments shall be performed by Formulation research and development
team.
5.4.4 Based on the process knowledge (developmental study reports and optimization/design
study reports) the FRD shall provide the Master formula Records (MFR), Component
Specifications, Critical Control Parameters etc.

5.4 Process Qualification:

This stage shall be where process design is evaluated to determine whether it is capable of
reproducible commercial manufacturing.
This stage has two elements as:
5.5.1 Design of a Facility and Qualification of Utilities and Equipment’s:
Proper design of facility, utilities, equipment’s and instruments shall be selected based on the
requirement of the manufacturing process. Before initiating process performance qualification
facility, utilities, equipment and instruments shall be in qualified state. Such activity shall be
documented, reviewed and approved by the trained personnel.
5.5.2 Process Performance Qualification (PPQ)
5.5.2.1 PPQ shall be used to confirm the process design and demonstrate that commercial
manufacturing process performs as expected.
5.5.2.2 Based on process understanding & process knowledge gained from Process Design
(Stage-I) and Process optimization/scale-up batches, critical process parameters shall
be monitored during the PPQ study. The PPQ involves the execution of the
manufacturing process in accordance with the critical process parameters and critical
quality attributes under the pre-approved PPQ protocol that includes the PPQ strategy,
sampling plans, test methods and pre-determined acceptance criteria. Where
appropriate, the data required to generate measurable statistics relevant to process
monitoring shall be defined within the PPQ protocol and/ or report.
5.5.2.3 PPQ shall have a higher level of sampling, additional testing, and greater scrutiny of
process performance than would be typical of routine commercial production based in

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identified risk. The level of monitoring and testing should be sufficient to confirm
uniform product quality throughout the batch.
5.5.2.4 As a base line consecutive three batches shall be considered for PPQ however it may
be extended based on the product or process complexity to collect the sufficient data
for evaluation.

5.5 Pre-requisites for Process validation/PPQ:

5.2.1. All associated equipment/systems/utility that have a direct impact on product quality
must be qualified before undertaking process validation batches.
5.2.2. Performance Qualification for new equipment can be done along with validation batch
and whenever required.
5.2.3. Personnel involved in the PPQ/Process validation shall be appropriately trained and shall
have product/ process understanding.
5.2.4. All the raw materials suppliers must be qualified prior to manufacturing of validation
batches. All raw materials shall be tested and released by QCD as per approved
specifications.
5.2.5. Related master documents like: Master Formula Record (MFR), Batch Manufacturing
Record (BMR), Specification & Testing procedure (SP&TP), must be effective and
available. All analytical testing method should be validated prior to execution of process
validation.
5.2.6. Summary of process optimization/ scale-up batches whenever required.
5.2.7. A copy of product development report/ summary (for new product)
5.2.8. All SOPs associated with the process being validated must be written and approved.
5.2.9. All the measuring devices must be within due date of calibration. The equipments used
for manufacturing should be with in preventive maintenance schedule.

5.6 Process validation Protocol/PPQ & Report Numbering:

5.6.1 Numbering system for PPQ/Process validation Protocol shall be as followed as:
Mx/PVY/AABB/ /XXX/ZZ

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Where
Mx: Module number.
PV: Stands for Process validation.
Y: P- Stands for Protocol & R-Stands for Report.
AABB: Indicates the alpha numerical Product code, where AA – Drug Code & BB – serial
number for that Drug Code irrespective of strength/percentage/ particle size variation etc
starts from 01 onwards .
XXX= Stands for Protocol serial number starting with 001,002 and so on.
ZZ= stands for Revision Number of the Protocol (Starts from 01 Onwards).
5.6.2 Process validation protocol number shall be entered in the register Format No.:
QAD/017/F03 prior to Approval.
5.6.3 The Interim report shall have the same number as the validation report except that the
alphabets PVR shall be replaced with the alphabets PVR-I- and a provision shall be made
in the Interim report number to include the serial number of the interim report starting
from 01. e.g. the first interim Process validation report number shall be
Mx/PVR-I/AABB/XXX/ZZ/01 while the second report number shall be
Mx/PVR-I/AABB/XXX/ZZ/02.

5.7 Process Validation/Process Performance Qualification Protocol:

5.7.1 PPQ/Process validation protocol shall have the following contents, but not limited to
5.7.2 Index/Content section describes the content with page number of the Protocol.
5.7.3 Objective shall specify the validation study.
5.7.4 Scope shall clearly define the product which is under the validation study and stages of
validation.
5.7.5 Reason for PPQ/Process validation shall be mentioned in the Protocol.
5.7.6 Roles and functionality of individual validation team member should be clearly defined.
5.7.7 Product Details: This shall include product name, strength, shelf life, label claim, batch
size, MFR No., BMR No., Batch No., In-process specification and Finished Product
Specification.

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5.7.8 Manufacturing Formula shall be mentioned.

5.7.9 All personnel involved in process validation activity shall undergo protocol base training.
5.7.10 Qualification details of equipment’s or instruments used in the manufacturing or testing of
a product shall be qualified for use.
5.7.11 Flow chart with brief description of the process, Process shall be defined in terms of a
stepwise flow-chart and with process controls with the identified critical process parameter
and critical quality attributes in process steps.
5.7.12 Selection criteria for critical process parameter and critical process attribute identification
of different processing stages and control variables. This section defines critical process
parameter and critical quality attributes at each stage of operation. These parameters shall
be monitored throughout the batch. Other attributes related to process shall be identified
and recorded in the report.
5.7.13 Sampling plan section shall define the sample detail - where (drawing of sampling plan),
when, how and how many. The sampling location is decided based on the design of the
equipment and worst-case point. The sampling plan shall be decided based on the
identified critical process parameter. The sampling technique shall be clearly specified in
the protocol whereas the sample quantity shall be designed as per the no. of test required
along with the acceptance criteria at each and individual steps. The reference of
specification and testing procedure shall also be provided against each test parameter.
5.7.14 Where ever, hold time study is planed refer QAD/SOP/024(Hold time study)
5.7.15 The validation batches shall be charged for stability (whenever required) and shall be
tested as per the individual stability study protocol, refer QCD/SOP/010 (Stability studies)
5.7.16 Process validation Protocol shall be prepared, reviewed and approved by prior to execution
of batch as mentioned in the Format No.: QAD/017/F01.
Note: For Exhibit batches: Use at least two discrete API lots/batches in any of three exhibit
batches of drug product related to regulatory market i.e. a single lot/batch of API be used to
manufacture one exhibit batch, and a second single lot/batch of API be used to manufacture a

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second exhibit batch of drug product, any one of the exhibit batch of drug product shall be
manufactured using a combination of two API lots/batch if needed and/or single API lot/batch.
API LOT/Batch Exhibit Batches
API lot/Batch 1 Batch 1
API lot/Batch 2 Batch 2
API lot/Batch 3 or 1 or 2 or a mix of 1&2 Batch 3
5.7.17 If any additional test or Process needs to be added and whenever required in the batch
shall be routed through addendum. Addendum shall be prepared using same format
number as used for Process validation Protocol.
5.7.18 The Addendum shall have the same number as the validation Protocol with A and a
provision shall be made in the addendum to include the serial number starting from A01.
e.g. the first addendum to Process validation Protocol number shall be
Mx/PVP/AABB/XXX/ZZ-A01 while the second addendum number shall be
Mx/PVP/AABB/XXX/ZZ-A02. Addendum shall be Prepared by QAD and reviewed by
FRD/PRD/QCD (as applicable) and Approved by QAD head/ Designee. Content and
objective of the addendum may vary as per requirement.

5.8 Process Validation/Process Performance Qualification Report:

5.8.1 PPQ/Process validation report shall have the following contents, but not limited to:
5.8.2 Discuss and cross-reference of all aspects of protocol.
5.8.3 Summarize data collected and analyze the data, as specified by the protocol.
5.8.4 Evaluate any unexpected observations and additional data not specified in the protocol.
5.8.5 Deviation report/incident: Any deviation/incident during validation shall be reported,
classified, and justified. Based on the impact assessment, immediate action as well as
further CAPA shall be initiated. Proceeding for further step of manufacturing, shall be
decided based on the assessment.
5.8.6 Summary about the critical process parameters and critical quality attributes shall be
reported.

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5.8.7 Conclusion: If the validation data meets the acceptance criteria, the process shall be
declared as “VALIDATED”. If the validation data does not meet the acceptance criteria,
the process shall be declared as “NOT VALIDATED”.
5.8.8 Recommendation: Upon completion of the review, recommendations shall be made on the
extent of monitoring and the in-process controls necessary for routine production. Based
on the final outcome, related documents like MFR, BMR etc. shall be revised as applicable
and same shall be followed for commercial batches.
5.8.9 Not executed all validation batches as per validation protocol interim validation report
shall be prepared.
5.8.10 Once validation study completed report shall be signed off by QAD personnel as
mentioned in the Format No.: QAD/017/F02.

5.9 Continued Process Verification:

The stage of continued process verification consists of collection of evaluation of
information and data about the routine commercial batches.
Continued Process Verification shall be done as per the current version of SOP No.
QAD/SOP/048 (Title: Continued Process Verification).

5.10 Concurrent validation:

5.10.1 In exceptional circumstances, where there is a strong benefit-risk ratio for the patient, it
may be acceptable not to complete a validation programme before routine production
starts and concurrent validation shall be used.
5.10.2 Concurrent validation shall be supported by proper justification and rationale. Concurrent
release shall be appropriate for process used infrequently for various reasons, such as to
manufacture drugs for which there is limited demand (e.g., orphan drugs, minor use
drugs). Concurrent release shall also be appropriate for drugs that are medically necessary
and are being manufactured in coordination with the agency to alleviate a short supply.
5.10.3 Each concurrent released product shall meet all quality attributes and shall have an interim
report duly reviewed and approved prior to distribution of the batches.

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5.10.4 Conclusions about a commercial manufacturing process can only be made after the
PPQ/Process validation protocol is fully executed and the data are fully evaluated.
5.10.5 Concurrent release batch shall be inclusion in stability program, it is important that
stability test data be promptly evaluated to ensure rapid detection and correction of any
problems.
5.10.6 Any complaints on such concurrently released products should be subjected to expedited
investigations and root cause analysis.
5.10.7 The PPQ stage for a process shall be considered closed, post successful completion of the
Process Qualification stage and evidence that, the process is observed to be reproducible
and product meets pre- determined quality attributes is demonstrated.
5.11 Failure Considerations:
5.11.1 If any PPQ/Process validation batch fails to meet the acceptance criteria, the failure must
be formally investigated through an investigation to determine the root cause. The
validation committee shall confirm the failure in any of the following categories.
5.11.2 Type-I: Where the root cause, reveals that the failure is attributed due to an ‘Non-Intrinsic
causes” such as, equipment/utility failure or faulty raw material. In such cases (i.e) Type I
failure, the validation activity can be substituted with another batch in lieu of the failed
batch.
5.11.3 Type-II: Where the investigation is unable to identify the root cause or the identified root
cause reveals that the failure is attributed due to an ‘Intrinsic causes” (i.e) CPP failure. In
such cases (i.e) Type II failure, PPQ/Process validation study is deemed to be unsuccessful
and the study should be repeated, only after taking necessary CAPA and other remedial
measures.

5.12 Change control:

5.12.1 Change control is considered to be fundamental and essential component of validation
process to maintain its validated state.

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5.12.2 The significant changes to items/systems that may affect product quality or the reliability
of process to control shall be evaluated for its validation requirements as part of the change
control systems.

5.13 Re-validation/ PPQ:

5.13.1 The extent of revalidation shall depend on the nature and significance of the changes.
PPQ/Process validation criteria shall include but not limited to
5.13.2 Change in batch size (scale-up/scale down) exceeding more than 10x, where x refers to the
approved batch size by regulatory agency.
5.13.3 Change in manufacturer of drug substance (API) for alternative vendor.
5.13.4 Change in functional excipient or any critical raw material.
5.13.5 Change in critical process parameter beyond approved limit.
5.13.6 Change in operating principle of the processing equipment.
5.13.7 Change in facility and support systems which have substantial influence to the process.
5.13.8 Transfer of existing commercial process from one site to another site.
5.13.9 Unusual or abnormal trends in quality parameters of product through APQR
recommendations.
5.13.10 As per customer requirement/based on the assessment.
5.13.11 In case a process is validated earlier in a set of same equipment (like to like) Process
validation is not applicable based on equivalency report/ assessment/ Justification.

6.0 ABBREVIATIONS:
6.1 SOP : Standard Operation Procedure.
6.2 PPQ : Process Performance Qualification.
6.3 CPV : Continued Process Verification.
6.4 CQA : Critical Quality Attribute.
6.5 CPP : Critical Process Parameters.
6.6 QAD : Quality Assurance.
6.7 FRD : Formulation Research and Development.

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6.8 QCD : Quality control.

6.9 API : Active Pharmaceutical ingredient.
6.10 CAPA : Corrective Action and Preventive Action.
6.11 MFR : Master Formula Record.
6.12 BMR : Batch Manufacturing Record.
6.13 SP&TP : Specification and Testing Procedure.
6.14 GMP : Good Manufacturing Practices.
6.15 WHO : Word Health Organization.
6.16 US FDA : United States Food and Drug Administration.

7.0 RELATED DOCUMENTS:

7.1 Formats:

S.No. Format Title Format Number

01 Process validation protocol QAD/017/F01
02 Process validation report QAD/017/F02
03 Process validation log book QAD/017/F03
7.2 Annexure:
S.No
Annexure Title Annexure Number
.
01 Overall sequence of Process Validation QAD/017/A01

END OF THE DOCUMENT

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