Blog

Standard Operating Procedure & Guideline for preparation and control of Validation Master Plan (VMP) for Instrument, Equipment, Facility in the pharmaceutical drug manufacturing plant.

SOP for Validation Master Plan (VMP)

1.0   PURPOSE

• • The purpose of this SOP is to lay down the procedure of preparation and control of the Validation Master Plan (VMP).

2.0   SCOPE

• • This SOP shall be applicable as such for the preparation and control of the Validation Master Plan (VMP) at the Pharmaceuticals manufacturing plant.

3.0   RESPONSIBILITY

• • The technical staff of QA

• • To prepare validation master plan (VMP)

• • To review the validation master plan for technical adequacy.

• • Head cross-functional department or designee

• • To provide relevant information and technical assistance for the preparation of the validation master plan (VMP).

• • To review the VMP for technical adequacy.

• • Head operation/Plant Head

• • To approve the VMP

• • Head Quality Assurance

• • To approve validation master plan.

• • To ensure implementation and compliance of the VMP.

• • Head Regulatory Affairs (RA)

• • To approve the validation master plan (VMP).

4.0   PROCEDURE – VALIDATION MASTER PLAN (VMP)

• • What is Validation Master Plan (VMP):

• • The validation master plan serves as a roadmap that helps to set the course, justifying the strategy, outlined the test and acceptance criteria, and documenting the necessary program that ensures a continuing state of validation.

• • Validation Master Plan (VMP) Contents

• • VMP shall contain the contents and information enclosed with content shall be as follows:

• • Approval

• • Index

• • Introduction:

• • Scope of validation master plan (VMP).

• • VMP structure

• • Validation execution methodology.

• • Validation and qualification policy.

• • Hierarchical system for validation document.

• • Quality risk assessment policy.

• • Validation/ Qualification approach.

• • Qualification protocol content and structure.

• Description of facility and plant.

• • Qualification activities:

• • User requirement specification.

• • Design specification.

• • Factory acceptance test.

• • Site acceptance test.

• • Installation qualification.

SOP for Equipment/ Facility Qualification

• • Operational qualification.

• • Performance qualification.

• • Impact assessment and validation & qualification requirement.

• • Equipment / facility decommissioning/dismantling program.

• • Legacy system and equipment.

• Qualification Categories:

• • Equipment/system/instrument qualification.

• • Facility/Area qualification.

• • Vendor qualification.

• • Personnel qualification.

• Utility Qualification and validation:

• • Critical /direct impact support system.

• • Non-critical support system.

• • Water system.

• • Compressed air system.

• • Nitrogen generation system.

• • Heating, ventilation, and air conditioning system.

• Validation categories:

• • Media fill (process simulation).

• • Process validation and Optimization.

• • Hold time study.

• • Stability studies.

• • Cleaning validation.

• • Disinfectant efficacy validation.

• • Computer system validation.

• • Analytical method validation/transfer.

• • Transport validation.

• • Temperature mapping.

• Documentation and Support System.

• • Documentation control system.

• • Change control system.

• • Personal planning and schedule.

• • Preventive maintenance.

• • Standard operating procedure.

• Sop cross-reference.

• • Abbreviation

• • Revision history.

• Revision and document control of Validation Master Plan (VMP):

• • VMP can be revised in case of any change in the defined validation/qualification approach to incorporate the changes through change control and the revision shall be done when any addition/deletion of equipment.

• • All the annexures shall be revised independently as and when required or annual.

• • The document number shall be assigned as QA/YYY/ZZZ where:

• • • QA: Stands for Quality Assurance

• • • /: Slash

• • • YYY: (VMP) Validation master plan

• • • /: Slash

• • • ZZZ: Serial number.

• • Document Revision number shall be 00 for first (new VMP) then 01, 02 as per subsequent revision.

• • Annexure and addendum (wherever required) shall be prepared by QA, as per template provided in attachment shall be checked by Head QA.

• • An approved copy of the annexure and addendum shall be submitted to CQ by the QA department.

• • The validation master plan issuance and control log book shall be maintained by the QA department.

• • VMP shall be reviewed, approved, and authorized by the responsible authority before execution.

• • In case the document is required to given/submit to any regulatory agency, a photocopy of the validation master plan (VMP) shall be taken and each photocopied page shall be stamped “UNCONTROLLED COPY” in blue color stamp and this copy shall be given to them.

• • Each page of “VALIDATION MASTER PLAN” shall be stamped as “MASTER COPY” stamp of red color.

• • If any validation/qualification criteria are not applicable to the site they shall be excluded and if any additional criteria require it shall be included in VMP.

• • Company present strategy shall be defined and a plan for future validation and qualification activities shall be defined in VMP.

5.0   ATTACHMENT – VALIDATION MASTER PLAN (VMP)

Attachment – VMP issuance and control logbook

VALIDATION MASTER PLAN ISSUANCE AND CONTROL LOG
Sr.No.	Date	VMP no	Issued to (Name and address)	Type of copy issued	No of copy issued	Issued by	Acknowledgment of recipient	Remark

• The attachment given below in table shall be attached with VMP as annexure:

• A)  Site plan

The layout shall be attached to this annexure.

• B)  Validation matrix

Equipment List (Area…)

				Qualification/validation requirement
Sr. No.	Name	Equipment ID	Category	URS	DQ	IQ	OQ	PQ	RQ

 

Prepared by

Checked By

Approved by

• C)  Qualification – categories

• D)  List of production equipment.

The List shall be prepared/ handled through separate respective SOP’s.

• E)  Equipment requalification schedule

Sr. No.	Equipment name	Equipment No.	Initial Qualification on	The last Re-Qualification done	Next requalification due on
						Jan	Feb	Mar	Apr
					Schedule on
					completed on

• • F)  List of quality control instruments

Sr. No.	Name	Number	Make / Model	Location

• G)  QC equipment/instrument requalification schedule

Sr. No.	Equipment Name	Equipment No.	Initial Qualification On	Last Re-Qualification Done	Next Re-Qualification Schedule For Year –
						Jan	Feb	Mar	Apr	May	Jun
					Schedule on
					completed on

• H)  Water monitoring schedule

Water monitoring schedule shall be handled through separate respective SOP’S

• I)  Qualification plan for utility system

Sr. No.	System	Requalification Planned on	Qualification carried out		Next requalification schedule	Qualification carried out		Remark
			From	To		From	To

• J)  HVAC requalification schedule

Sr. No.	System No.	Supplied To	Initial Qualification Done On	Next Re-Qualification Schedule For Year –
					Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sep	Oct	Nov	Dec
				Schedule On
				Completed On

• K)  Validation categories

• L)  Media fill plan

Sr. No.	Size of vial	Type of vial	No. of batch	Last media fill done on	Media Fill schedule for the year  –                  (Injection line- )
						Jan	Feb	Mar	Apr	May	Jun	Jul	Aug	Sep	Oct	Nov	Dec
					Schedule on
					Completed on
					Schedule on
					Completed on

• M)  List of products for process validation

Sr. No.	Product Name	Generic Name	Batch no	Label Claim	Status	Completed on	Reason for last revalidation

• N)  Process validation protocol content

Process validation protocol content

• O)  List of products for cleaning validation

Sr. No.	Name of worst-case product	Name of active ingredient	Higher-strength	Solubility in water	Reason for cleaning validation	Cleaning validation status	Competed On	Next due on

• P)  List of equipment/system for PLC validation

Sr. No.	Equipment/System name	Equipment  NO	Initial  qualification on	Next Requalification due On	Requalification Done On	Next Requalification due On

• Q)  List of product analytical method validation/transfer

Sr. No.	Product Name/ API	Status	Completed on	Remarks

• R)  Temperature /RH mapping plan

Sr. No.	Area	Mapping plan	Mapping period	Status	Remapping frequency	Re-Mapping plan

• S)  QC instrument calibration schedule.

QC department’s instruments calibration planner shall be handled through separate respective SOP’S

• T)  Annual calibration planner

Plant annual calibration plan planner shall be handled through separate respective SOP’S.

• U)  Preventive maintenance planner

Plant Preventive Maintenance planner shall be handled through separate respective SOP’S.

6.0   REFERENCES

• • Recommendation on validation master plan installation and operational qualification, non sterile process validation cleaning validation (PI -006).

• • GMP for medicinal product for human and veterinary use annesure-15: qualification and validation (Eudralex-volume 4).