Pharmaceutical Validation Services (OSD Facilities)

Pharmaceutical validation is an important aspect of Quality management System(QMS) which ensures product safety, Efficacy & Quality. Pharmaceutical validation provides documented evidence that your systems, facilities and processes perform their intended functions according to established specifications.

Our team works under supervision of highly qualified & experienced professionals who faced many regulatory Audits i.e. USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa),ANVISA (Brazil) , EMEA (European Union)…etc.

We conduct validations when a new system, equipment or facility is adopted by an organization, or when a periodic study is needed with the professionals having rich experience, well trained in Good Documentation Practices, and well updated on current regulatory requirements.

Services we offer:

We carry out the following activities which includes Plan, Design, Preparation, Review of Pharmaceutical Quality Management System documents (VMP, SMF, SOP ... Etc.), Validation/Qualification Protocols (URS, QRA, DQ, FQ, FAT, SAT, IQ, OQ, PQ & RQ) and execution thereof.

Facility Qualification/Area Qualification( Existing & New facility(Green field Project )
Pharmaceutical Equipment/Instrument Qualification. I.e.

Process Equipment.

Packing line Equipment(Primary & secondary)

Warehouse Equipment.

Equipment Cleaning Validation
HVAC (AHU) Qualification
Pharmaceutical Water System Validation
Facility Environmental Condition monitoring i.e.

Area Temperature & Humidity mapping (Initial as well as seasonal Mapping for winter, monsoon& summer seasons.)

Computer System Validation(CSV) / Software Validation which includes,

PLC Validation

HMI & SCADA System Validation.

All Automated System

DGFT’s Serialization and Track & Trace System.

Vendor Qualification Documents/protocols.
Process Validation.
Hold Time Study.
Support in preparation of all regulatory audits readiness & justification for audit responses.

Note: We also take up the activities based on the organization/ industries requirements.

L-1/286 A, Kalkaji, Ali,
South Delhi, Delhi-110019

Mon - Sat 9.30am - 06.00pm
Sunday CLOSED

(+91)-965 476 1239
Call us for enquiry

Pharmaceutical Validation Services (OSD Facilities)

Services we offer:

For Business Enquiry

mavericKR Solutions is one of the world's leading management consulting firms.