Delivering Training Solutions for Pharmaceutical Analysis
Services: Training, Consultancy and Auditing
A range of training courses on laboratory related topics such as method validation & transfer, data integrity and HPLC.
Expert advice on laboratory related scientific and compliance matters.
Laboratory auditing against best practice and/or to required regulatory standards such as EU, FDA, etc.
Training on method validation and transfer may be combined with consultancy advice for a particular validation/transfer protocol and/or assistance with an in-house standardised approach and associated SOP.
Data integrity focused audits and gap analysis studies are often combined with training for staff on important aspects of data integrity in the laboratory.
Human error reduction consultancy may be combined with auditing to assess contributing factors and may identify remediation training and/or training design for in-house use.
We offer expert advice on all things to do with the analytical laboratory. You may need:
- Technical scientific advice about an unfamiliar topic;
- Advice regarding the typical expectations of regulatory authorities with respect to a particular topic;
- Troubleshooting advice for a particular problem or issue.
Consultancy may be performed either on site or remotely, whichever is most appropriate. Contact us with your problems.
Our expertise is in the area of chemical analysis of pharmaceuticals and biopharmaceuticals. We offer:
Often our services are interconnected and we can work with you to address particular issues using different approaches. Some examples include:
We have assisted many pharmaceutical and biopharm companies by providing advice on:
Data governance requirements; data integrity gap analysis studies to identify data integrity risk; reducing data integrity risk for specific software and analytical instrumentation; training for data integrity.
Method Validation & Transfer
Preparation of validation and transfer protocols; contents of general SOPs for method validation and transfer including acceptance criteria; troubleshooting problems related to method validation and transfer; review of method validation data;
Verification of Pharmacopoeia Methods
Requirements for method verification; review of protocols and reports; troubleshooting problems related to method verification.
Human Error Reduction
Identification of human error issues; evaluation of contributing factors which result in human error; design of training programmes to address human error.
Suitable approaches for developing effective and robust methods; troubleshooting method development problems.
Review of existing training programmes in terms of content and effectiveness; identification of learning needs (training needs analysis); design, delivery and evaluation of training courses.
Approaches to troubleshooting using a logical problem solving approach; technical issues and problems with HPLC.
Out of Specification (OOS) and Atypical Results
Review of OOS investigations to evaluate scientific rigour and regulatory compliance; review of CAPA effectiveness; review of OOS/atypical results SOPs.
Implications of ICH Q3D and pharmacopoeia expectations; methods development and validation.
What People Say About MTS:
N. Maguire, Allergan
"Extremely knowledgeable of ICH, USP FDA guidelines."
R. Lagah, Oxford BioMedica
"Very informative – good to know of areas we can improve on."
A. Reeves, ProMetic Biosciences
We offer laboratory specific auditing which allows a detailed
investigation of both compliance with the relevant regulatory standards, and
whether a sound scientific approach to analytical chemistry has been applied.
The MTS consultant, Oona McPolin, is an IRCA qualified lead auditor and has
extensive experience in auditing laboratories.
The focus of a laboratory audit may vary; common examples
- Audit of general
laboratory operations, or a specific element, against best practice.
- Audit against
required regulatory standards, e.g., EMA, FDA, etc.
- Data integrity
audits - laboratory audits will always focus on data integrity but we can
perform an intensive data integrity audit on selected elements of your quality
system, e.g., electronic and paper based data recording systems, laboratory
- Supplier audit,
e.g., contract laboratory
Contact us with your auditing requirements.
What People Say About MTS:
"Very knowledgeable from a QC perspective – 20yrs of
experience which is clear and can be seen when we ask questions. Relevant
auditor knowledge. Very eye opening of our issues."
T. O’Connor, Gilead