Specialist Pharmaceutical Consultants and Auditing

RQA’s specialist pharmaceutical consultants and auditors have extensive experience in quality and product safety in manufacturing operations throughout the pharma sector including medical devices.

GMP & GDP Audits

RQA will carry out GMP audits according to the European Medical Agency GMP and the US FDA CGMP requirements.  This will be for finished products or ingredients.  Following each audit, a detailed audit report is provided identifying corrective actions that will enable an effective Corrective and Preventative Action (CAPA) plan to be put in place.  The RQA auditor can also provide advice to assist the site to identify best practice improvements.  Our consultants also prepare our clients for regulatory inspections, ensuring best practices are followed.

GMP & GDP requirements:

EMA GMP

EMA GDP

US FDA CGMP

Product Recall Management

Product Recall Plan

A product recall plan is required by EU Guidelines on GMP and GDP.  The guidelines also expect companies to have appropriately trained personnel and for companies to test their recall preparedness by running recall simulations or mock recalls.  This fits exactly with RQA’s “Plan, Train, Test” approach.

“Appropriately trained and experienced personnel should be responsible for managing complaint and quality defect investigations and for deciding the measures to be taken to manage any potential risk(s) presented by those issues, including recalls.”

Ref: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Part 1 Chapter 8: Complaints, Quality Defects and Product Recalls

“There should be established written procedures, regularly reviewed and updated when necessary, in order to undertake any recall activity or implement any other risk-reducing actions.”

Ref: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Part 1 Chapter 8: Complaints, Quality Defects and Product Recalls

“The quality system should include an emergency plan which ensures effective recall of medicinal products from the market”.  Ref: EU Guidelines on Good Distribution Practice of Medicinal Products for Human use.  It states

“The effectiveness of the arrangements for product recall should be evaluated regularly (at least annually).” Ref: EU Guidelines on Good Distribution Practice of Medicinal Products for Human use.

Product Recall Training

RQA train the product recall or crisis teams of pharma companies to ensure they are prepared for a product recall incident.  The training includes examples of product recalls in your sector, an overview of relevant legislation and good practice, key processes including complaints, investigations, risk assessments, reporting and execution of recalls.  Our consultant will also provide training on key elements of your product recall plan to ensure the team understand their roles and responsibilities.  The day finishes with a mini simulation or mock recall to provide added realism to the recall process.

Click here for details on the training course

Product Recall Simulation

Our product recall simulations are customised to your specific company.  We will develop a scenario that will be challenging and relevant to your business.  The RQA consultants will role play a number of key stakeholders including customers, healthcare workers, retailers, regulators and media.  It will be a challenging exercise that is the best test of your product recall plans outside a real recall situation.  Following the simulation, a report will be provided detailing areas of development to ensure your recall team is best prepared for a recall situation.

Click here for details on the recall simulation

Quality and Risk Consultancy

RQA can provide consultancy in many areas related to pharmaceutical sector.  This includes a complete array of quality management support, risk management, investigation assistance as well as consultancy on compliance and regulatory affairs.

We can also provide support for medical device companies who are planning to undergo a conformity assessment by an accredited notified body for the approval of a medical device.  The RQA consultant will prepare the company for all aspects of the assessment.  RQA will provide support in all the areas that will be covered by the assessment which is an audit that focuses on a manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.

Our consultants also prepare our clients for regulatory inspections, ensuring best practices are followed.

Specialist Pharmaceutical Consultants and Auditing