Quality in the clinical trial process is essential in order to ensure data integrity and subject safety. TASK’s quality team oversees and ensures that the highest standard of quality is adhered to according to international standards.
Our QA team has experience in the GXP (GCP, GLP, and GCLP) across all phases and a variety of therapeutic areas. We have worked with a range of clients from small start-ups to global multinational companies and are flexible with our approach. Whether you require a full QA programme or assistance on a consultancy basis TASK Quality has the resource and knowledge to help you.
QA services offered:
Audits
Audits are a mainstay in the pharmaceutical industry. Failing to understand what each audit addresses and the related government authorities priorities can lead to gaps in compliance. This can result in warning letters, increased regulatory scrutiny, and penalties. To successfully avoid regulatory deficiencies, it is recommended that companies periodically conduct mock/external audits to ensure they are “audit ready”.
Audits are performed to verify conformance through the review of objective evidence to assess the effectiveness of processes, eliminate problem areas and achieve continued improvement.
TASK QA offers a variety of compliance audits:
1. Good Clinical Practice (GCP),
GCP governs how clinical research trials of human subjects must be conducted. Public safety is particularly critical to inspectors. Government regulatory authorities may perform announced or unannounced inspections for several reasons. TASK QA conduct GCP audits on behalf of Sponsors to ensure their selected sites are complaint with and studies are conducted according to GCP guidelines.
2. Good Clinical Laboratory Practice (GCLP)
GCLP is not addressed in GCP. GCLP is a combination of GCP and GLP. Studies have become more complex and sample collection from participants are intensified and most likely the primary endpoint of the study. To ensure quality output of sample collection, pre-analytical processing, storage, shipping, safety and/or end point testing, GCLP guidelines should be adhered to. GCLP is like any other ISO (International Organization for Standardization) – a clear guideline of a quality management system. GCLP basic principles can be implemented in any industry. TASK QA conducts GCLP audits to ensure high quality output of sample collection.
3. Good Pharmacy Practice (GPP)
Management of the Investigational product would be stipulated in the protocol and in some cases, documents derived from study setup e.g manual of operations. However, the management of the pharmacy as an entity and the management of concomitant medications are not described in these documents. TASK QA conducts GPP audits to ensure quality management of the pharmacy and compliance to good pharmacy practices.
4. Systems, Policies, Vendors & Documentation
a) TASK QA conducts audits on selected third party vendors – vendor processes and vendor compliance to protocol and service level agreements as part of Principle investigator and/ or sponsor quality oversight indicated in ICH GCP.
b) TASK QA conducts audits on the sponsor trial master file (TMF) – essential documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents are inspected by regulatory authorities during their inspection as they serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements to confirm the validity of the trial conduct and the integrity of data collected.
c) TASK QA can conduct audits on systems and policies used during the conduct of the trail to ensure compliance and standardization.
5. Developing Quality Management Systems (QMS)
QMS consists of written and controlled guidelines and procedures that form a foundation for all procedures. An organized QMS ascertains the steps for key processes and forms methods in preventing failures in a timely manner. QMS is organized to protect the brand, organization processes, and the customers’ interest. TASK QA can develop and assist to implement a new QMS or audit a current QMS, then report on required amendments and detail a roadmap to compliance.