Gary Ritchie
Garton Consulting
425 Old Oak Place
Thurmont
, MD 21788
Phone:
(240) 367-7125
Fax:
(240) 367-7125
E-mail: gary.e.ritchie@gmail.com
Web Site: www.garyeritchie.com
Specialties:
- Analytical
- Pharmaceutical
- Quality
- Spectroscopy, chemometrics, statistics, pharmaceutical water
Services:
Specialist in Near Infrared Spectroscopy and multivariate analysis of pharmaceutical manufactured products.
Expert in the use of Process Analytical Technology (PAT) solutions for drug substance and product development and manufacturing.
Assessment of PAT/Quality by Design (QbD) project for feasibility and proof of concept for no initial fee; includes:
- Establishing appropriate concentration and spectral range
- Determining appropriate samples for calibration and design space - Preliminary model building
- Perform Product Quality Assessment (PQA) of Drug Products
- Assessment of drug products specifications (methods, tests and acceptance criteria) for adherence to shelf life expiration dating through evaluation of stability data and trends, LIR s, events, and CAPA's.
- Assessment of QC controls (methods, method validation, validation protocols) established for the identified finished drug product lots.
- Write test record review reports consisting of laboratory investigations, method validation, stability reports and trends, and executive summary.
