About AKS GMP Advisors
AKS GMP Advisors is knowledge based fully integrated firm providing Technical training programs, audit and regulatory compliance.
AKS GMP Advisors offers a broad range of highly experienced and motivated professionals with hands on experience and technical expertise.
- Honesty and integrity
- We strive to show transparency in everything we do. ...
- We believe a reputation is built on being reliable. ..
PHARMACY INSTITUTES & STUDENTS
Industrial and regulatory updates
online technical guidance
Technical workshop of On Job Projects
Pharmaceutical Industry & Professionals
We provide GMP training as per requirements of the organization in the areas as under : WHO, TGA, MHRA, USFDA, EU, PICS & ICH.
GMP TRAINING PROGRAMME FOR PHARMACY STUDENTS (B.PHARM. & M.PHARM.)
Introduction of Pharmaceutical Industry
- Overview Of Pharmaceutical Industry (Worldwide).
- Overview and Classification of Pharmaceutical Manufacturing Plants in India.
- Description and role of all departments. (Production, QA, QC, Warehouse, Engineering, EMS, HR).
GMP (Good Manufacturing Practice) and Its Regulation.
- History of GMP and its evolution & progress and trends till date across the globe.
- GMP and its relationship with quality; from basics to specific requirements.
- Requirements, scope, objective and principles and practices of GMP with emphasis on GMP requirements of:
- The Revised Schedule M
Extensive Validation Studies & Techniques ( including qualification studies) for:
- Equipment design, installation, operation, performance ( 4Q approach from DQ-PQ ).
- Clean Room, HVAC & water systems validation with a Risk based approach to manufacturing of pharmaceuticals.
Manufacturing Methods and In-Process Quality Control.
- Oral Solid Dosage Form
- Liquid Dosage Form
- Semisolid Dosage Form
- Parenteral Dosage Form
Quality Mangement System, Change control, Deviation Handling, CAPA (Corrective and Preventive Action), Complaint handling and Product Recall.
Good Documentation Practice, Good Distribution Practice, Good Laboratory Practice, Data Integrity.
Record Preparation (BMR, BPR, MFR, SOP, Protocols), Computer System Validation, Handling of GMP inspections effectively and successfully.
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