Institute Of Pharmaceutical Management

GMP Compliance

Audit preparations : -

Evaluation of GMP compliance to International Regulatory Standards, covering the manufacture of Non-sterile formulations, such as tablets, capsules, creams, ointments, Formulations and API's to face Quality Audits such as WHO, USFDA, EDQM, MHRA, FDA etc.

Vendor auditing : -

IPM performs both initial qualification audits to approve a new supplier and on-going audits to meet the requirements of your supplier management program.

Documentation : -

based on USFDA, MHRA, WHO and ICH norms

Preparation Of Site Master File
Master Validation Plan
Standard Operating Procedures
Master Formula Records
Batch Manufacturing Records etc.

Regulatory Compliance: API and Formulation

DMF preparations and review for regulated agencies like USFDA, MHLW, MHRA, HEALTH CANADA, EDQM and other EU agencies and semi-regulated agencies

Dossiers preparation and review of regulatory markets (US, Europe, Japan, Canada, etc) as well as for semi regulatory markets.

Handling deficiencies raised by regulatory agency

Amendments and annual updates of current DMFs

Revision of current CEPs

Expert report (QOS) preparation

Handling queries of other EU agencies with reference to MAA

Specific areas like polymorphism, genotoxicity etc.

Classroom training in

-	Drug Regulatory Affairs
-	Pharma Quality
	Management
-	Diploma in Quality
	operations and
	Regulatory Affairs
-	Patents
-	Clinical research

Distance Participation Programs

-	Drug Regulatory Affairs
-	Pharma Quality
	Management

GMP & Regulatory Compliance

Listen to Francisco Gomez from Spain

Practical training on eCTD