QA / GMP Support for Pharmaceutical and Medical Device Companies

Written by SeerPharma | Aug 19, 2024 4:37:10 AM

SeerPharma consults on 100 to 150 projects every year. Many of these engagements with pharmaceutical and medical device companies involve providing ongoing support for business needs related to Quality Assurance (QA) and Good Manufacturing Practice (GMP) compliance. Our clients continue to rely on our expertise for regular remote and on-site support in the following areas:

Quality Management Systems (QMS)

Maintain the QMS to ensure alignment with regulatory requirements.
Facilitate the regular review, update, and creation of QMS documentation.

Compliance and Regulatory Affairs

Prepare for regulatory inspections and supplier audits as needed.

Documentation and Record-Keeping

Maintain accurate, comprehensive records of all quality-related activities.
Review batch records, validation protocols, and reports.

Audits and Inspections

Manage responses to findings from internal and external audits, including risk assessments.

Deviation and CAPA Management

Investigate deviations, non-conformances, and quality issues, including the implementation of necessary Change Control (CC) processes.
Develop and implement corrective and preventive actions (CAPA).

Training and Development

Develop and deliver training programs on quality standards, procedures, and regulatory requirements.
Oversee staff training records.

Continuous Improvement

Identify opportunities for process improvements and implement changes to enhance product quality and efficiency.

SeerPharma’s team of seasoned professionals provides clients with trusted guidance and support in these activities on an ongoing basis. Engagements can vary from a single day to several days each month, offering organisations the flexibility to access experts who are well-acquainted with their business operations.

For more information about SeerPharma’s consulting services, please visit:
SeerPharma QA and GMP Consulting Services

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