QA System Implementation

Our experience covers national and international projects, with consultants specialized in GxP who provide support in many different areas related to Quality Assurance and who can implement a Pharmaceutical Quality System (PQS).

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Services provided by our QA business line include:

Development of the Contamination Control Strategy (CCS), according to Annex 1 of the EU GMP, based on our knowledge in the field of aseptic processes, both equipment production and engineering and consulting applied to the design of GMP installations worldwide.
Product Quality Reviews (PQRs).
Drafting of Standard Operating Procedures (SOPs).
User Requirements Specifications (URS).
Non-conformities management with Root Cause Analysis and Corrective & Preventive Actions (CAPA) Management.
Gap assessment (carrying out GAP analysis) and implementation of quality systems according to GMP (EU, FDA), GDP, ISO 13485 (medical devices), etc.
Preparation and support for FDA Pre-Approval Inspections (PAIs).
Data Integrity: Defining the governance framework to set a data integrity culture.

Internal quality audits play a key role and are an essential element of our quality assurance services. In them, our subject matter experts help to ensure the regulatory compliance of companies through site visits, documentation review and meetings with the client’s key personnel to issue an audit report aimed at successfully passing the GMP (EU, FDA), GDP, ISO 13485 (medical devices) inspections of the company. Inspections can be executed by regulatory Agencies and competent authorities and/or by their clients.

Quality risk management is another essential aspect of the services provided by Telstar. Decisions are made based on risk assessment in accordance with the ICH Q9 Guide and integrated throughout the product lifecycle.

Examples of risk-based and risk-based decisions:

Risk assessment to define particle counting points for cleanroom classification (new requirement on EU GMP Annex 1).
Risk analysis to define the sampling points for the environmental monitoring program (including particle counts, active and passive microbiological monitoring, etc.) in clean rooms.
Definition of critical and non-critical quality attributes and definition of critical and non-critical process parameters.
Justification of the Environmental Monitoring Plan.
Risk-based internal or external quality audit programs.
Supplier Qualification.
Definition of critical instruments and, based on this, definition of calibration frequencies.
Change Control Management (new in ICH Guide Q12).
Scope or frequency of validation, justified in the validation master plan.

Our work methodology is very flexible, always considering client needs and requirements, being able to provide support with in-plant on a full-time or part-time basis, through a pool of consulting hours to be consumed as needed or per a specific project.