GMP Consulting

Name: Micron HVAC Pvt. Ltd.
Address: Greens Center, O-309 / 310, S. No.26 CTS No. 5401, Thergaon,, pune, 411033, IN
Telephone: 020 29529739

GMP Auditing

Conduct mock audits of clients' site to determine readiness for FDA inspection
Due diligence audits
Third party audits on behalf of procurement companies
GAP assessment audit

GMP Training

We can develop and deliver a comprehensive and meaningful in-house training program that is tailored to, and appropriate for, client's specific needs.
In-house training is the most cost-effective means to improve the skills and capabilities of the employees.
It is helpful because of convenience and less disruption, value for the money, save time, provide freedom of expression and maintain confidentiality, provides freedom to discuss client's own case studies, better interaction and effective learning.

Microbiology

Review of microbial testing methods/ procedures viz., Growth promotion testing, Microbial limit testing, Sterility testing, antimicrobial & preservative effectiveness, Bacterial endotoxins testing, Water testing etc.
Development of Environmental Monitoring (EM) program.
Development of contamination control program.
Development of microbiology method validations protocol.
Development of admixture studies.

Setting-up Facility

Setting up Quality control and Quality assurance department.
Setting up Microbiology laboratory
Settling up Injectable facility.
Review of layout of finished dosage manufacturing facility.
Setting up cleanroom laundry facility of a multinational company in India.
Setting up world class desiccant manufacturing facility.
Review of validation protocols and reports.
Reviewing company practices and providing advice on changes to systems in line with regulatory expectations.
Development of Quality Management Systems (QMS)/Pharmaceutical Quality Systems (PQS).

Aseptic Processing

Provide support in development of Aseptic Process Simulation.
Equipment procurement
Qualification of equipment
Qualification of facility
Qualification of utilities
Process validations (Terminal Sterilization and Aseptic Processing)

Regulatory Services

Review of Abbreviated New Drug Application (ANDA) submissions.
Review of Drug Master File (DMF) submissions.
Guidance for preparation of ANDA and DMFs.
Support in preparation of Remedial Action Plan (RAP) post FDA inspection.
Provide support in drafting response to regulatory audit observations.

GMP Consulting

GMP Auditing

GMP Training

Microbiology

Setting-up Facility

Aseptic Processing

Regulatory Services

Services Provided

Our Services

Service Offering

Israel

Saudi Arabia

UAE

Nigeria

Ireland

Bangladesh

Vietnam