GMP TRAINING for GMP QUALITY ASSURANCE,GLP training course India

GMP and GLP for QA and QC

Duration : Two days
Language/s : English or per organization’s need.

GMPs and GLPs - Evolution and Expansion and applicability to the R&D set-up, correlation with plant activities.
Quality assurance principles and practices : applications to the R&D set-ups per expectations of global regulatory agencies.
Applicable R&D GMP guidelines as WHO TOT, API for clinical trials – ICH Q7, EU GMP annex 13, Development of multisource generic products.
R&D process flow – from exploratory research to CTM manufacturing.
Technology Transfer - Responsibilities of the sending and receiving units towards method, API and different pharmaceutical formulation transfers.
Requirements and expectations of the international auditors in terms of QA and GLP from the R&D set-ups.
Equipment and Instrument Qualification and Process validation – requirements and inputs – handling process change requests.
Quality risk management - adopting a risk based approach from process design, development, transfer and verification.
Documentation - good practices, TTD packages, SOPs, reports, forms and formats.
Handling R&D GMP inspections / audits Successfully and effectively.
Normative references to Quality by design ( QbD ), ICH Q8, ( Pharmaceutical development ), Q10 - Pharmaceutical quality systems and Q11 Development and manufacture of API.
Maintaining the Quality Continuum for development activities.

GMPs and GLPs - Evolution and Expansion.
Quality assurance principles and practices : applications to the control laboratories.
QA and GLP requirements in a nut shell of US FDA, WHO, TGA, PICS, MHRA, EU, MCC, HPFB, ICH, SCHEDULE L1 covering :
- Lab design and necessary facilities, systems of procurement of lab chemical and glassware
- Training requirements for R&D, R&DQA and QC
- Analytical Instrument Qualification
- Calibrations from Concepts to Clarity
- Quality Assurance and Lab documentation ( all SOPs, note books, protocols, formats and likes )
- Requirements of Microbiology lab
- Overview of key QA drivers as PQR, Validation, Deviation Management, Change control, OOS and Internal Audits as applicable to the development lab
- Overview of Stability studies and method transfer, validation and verification.
Facing GLP audits and correcting non compliances.