The Validation Master Plan (VMP) describes all validation requirements for the production facility. It covers validation aspects for all production areas, storage, utilities, and staff facilities. The VMP ensures processes will consistently produce products that meet specifications. It describes the principles of validation and organization of qualification activities and equipment.

1. Validation Master Plan
Mirza Danish Hussain Barlas
Assistant Manager Business Development and Regulatory Affairs
(Pharm-D , R.Ph, MBA Mkt, MBA Sc, CRCP)

3.  A validation Master Plan (VMP) is a comprehensive
document describing the applicable validation
requirements for the facility, and providing a plan for the
meeting those requirements.
 Scope: VMP includes all relevant aspects relating to the
production of Pharmaceuticals in the production facility.
The principle of validation, the organization of
qualification and equipment are also described. It covers
all facilities used in various production areas, storage,
services and the rooms for staff.
 * In short, it is documented evidence that provides a high
degree of assurance that a specific process will
consistently produce a product the meets its
predetermined specifications and quality attributes.

4.  The user requirement(s) document (URD) or
user requirement(s) specification is a
document that specifies what the user
expects the machine to be able to do.

5.  A functional specification (or
sometimes functional requirement
specifications) is a formal document used to
describe in detail a machines intended
capabilities, appearance, and interactions
with users.

6.  A technical specification (or
sometimes technical requirement
specifications) is a formal document used to
describe in detail the requirements for a
machines use.

7.  The first element of the validation of new
facilities, systems or equipment is design
qualification (DQ).
 The compliance of the design with GMP
should be demonstrated and documented.

8. Installation qualification (IQ) should be performed
on new or modified
facilities, systems and equipment.
IQ should include, but not be limited to the
following:
(a) installation of equipment, piping, services and
instrumentation checked to
current engineering drawings and specifications;
(b) collection and collation of supplier operating
and working instructions and
maintenance requirements;
(c) calibration requirements;
(d) verification of materials of construction.

9. Operational qualification (OQ) should follow Installation
qualification.
OQ should include, but not be limited to the following:
 (a) tests that have been developed from knowledge of
processes, systems and
 equipment;
 (b) tests to include a condition or a set of conditions
encompassing upper and ower operating limits,
sometimes referred to as “worst case” conditions.
The completion of a successful Operational qualification
should allow the finalization of calibration, operating and
cleaning procedures, operator training and preventative
maintenance requirements. It should permit a formal
"release" of the facilities, systems and equipment

10. Performance qualification (PQ) should follow successful
completion of
 Installation qualification and Operational qualification.
 PQ should include, but not be limited to the following:
 (a) tests, using production materials, qualified substitutes
or simulated product,
 that have been developed from knowledge of the process
and the facilities, systems or equipment;6
 (b) tests to include a condition or set of conditions
encompassing upper and lower operating limits.
 Although PQ is described as a separate activity, it may in
some cases be
 appropriate to perform it in conjunction with OQ.