Expert inspection and technical services for the pharmaceutical industry

Our Services

Mock Regulatory GXP Inspections

Regulatory Inspections performed by former regulators.

We can perform mock inspections to cater for your needs be it a first mock inspection prior to receiving your licence application inspection or a facility that just needs some independent eyes to check its inspection readiness.

This can be solo former inspectors or a team of former inspectors and experts depending on your needs and timescales.

In-house training, education, coaching and workshops

The founder and the many associates have decades of experience in training quality, laboratory, engineering, finance, HR and production personnel. We have some ready-made training packages and can also tailor-make any materials to suit your specific challenges and needs including the preparation of bespoke video training courses such as GMP Induction training.

Inspection preparation and inspection support

Inspections are all about demonstrating compliance. We can put you on the right path for you to showcase how brilliant you are and also identify any compliance gaps, how to storyboard these and mitigate the impact of these compliance gaps during inspections.

We can provide assistance during an inspection on how to address questions and prepare staff sitting in front of inspectors on how to interact with the inspectors. All inspections (usually) yield at least one observation so if you need any assistance with responding to the observation, and understanding the extent of the response needed, then we can also guide you in that.

Data Integrity Governance Checks

We can guide you on where to start in ensuring your controls are inspection tight and ensure your Data Integrity Governance in place meets the mark.

Pharmaceutical Quality System (PQS) Maturity Checks

Heard a lot of chatter about Pharmaceutical Quality System Maturity and unsure if your Pharmaceutical Quality System is mature enough to meet the current and future regulatory needs? We can perform an in-depth analysis of the current design and monitoring controls to see if these are hindering or helping you.

Third-Party Audit management

We can help you with external audits of your third-party suppliers or contract organisations.

Need a Qualified Person level assessment of these third parties? That’s also not a problem as some associates are also eligible QPs in addition to former inspectors and some associates are just really good QPs!

Gap Analysis services

Gap analysis helps you direct your resources and focus the attention of staff.

These can be used prior to inspections to assess areas where you feel you have weaknesses or gaps against current regulatory requirements.

These are also often performed in response to a regulatory observation to understand the deficiency depth and breath so that the improvement plan needed addresses the holistic nature of the deficiency.

Due Diligence and Technical Support

We have assisted in activities as part of mergers and acquisitions to dive in deep into the processes, product files and histories to uncover any vulnerabilities that may not be immediately visible or disclosed. These also identify potential compliance gaps in existing systems even if the site has current GMP certificates.

Associates

TM Pharma Group has currently over 10 associates and rising who collaborate on assignments to ensure the best possible fit for your organisation and needs can be provided for.

We only work with associates which are known to the founder and have demonstrated competence or come with solid referrals. This isn’t always an ex-inspector but also carefully selected industry experts and friendly people as a bonus.

GXP – we have a range of ex-inspectors able to assist from GCP, GMP, GQCLP to GDP services

Qualified Persons – We do not offer Qualified Person services for certification but some GMP associates are Qualified Persons as a minimum professional status level.

Collaborators – we have a number of collaborators across UK and EU to assist you with your regulatory application needs.

Annex 1 Sterile Medicinal Products readiness

Are you ready for the implementation of EU/PICs/WHO GMP Annex 1? A readiness review against the updated annex can be performed so you know where your vulnerabilities lie or we could assist you with focusing on specific areas and need to understand the intent behind the words

Compliance Management and Remediation (including MHRA Compliance Monitors)

From April 2022, the MHRA will be running a pilot scheme to monitor companies that fail to comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and are referred to the Inspection Action Group (IAG) after an inspection that has resulted in the compliance escalation process being initiated.

The pilot facilitates reducing potential shortages in the supply of safe medicines through the use of risk-based supervision and monitoring. The process will also assist the MHRA in concentrating resources on delivery of the routine risk-based inspection programme, thus further ensuring patient safety.

During the pilot scheme, the MHRA will review referrals to the IAG and where these referrals are considered suitable, the company may be offered the option of using Compliance Monitors (CM) to oversee the implementation of an agreed Compliance Protocol (CP). A company offered the CM oversight route may choose not to accept this and can continue with the routine IAG process.

This independent oversight from the Compliance Monitor will enable the company to focus on the remediation of the corrective actions and augment the regulatory oversight of the MHRA.
TM Pharma Group has staff and associates deemed eligible to act as Compliance Monitors.

Contamination Control Strategies

We can help with providing guidance on how to assemble the Contamination Control Strategy (CCS) within an accepted framework and can review current arrangements to see if it meets the expectations.

We can also advise on what format is best if you are a CDMO to navigate the confidentiality arrangements

Investigations

Do you need some extra support with investigations?

We specialise in the review of inspection critical investigations such as product defects, sterility assurance or Aseptic Process simulation (media fill) failures. This can be performed remotely and charged by 2 hourly blocks of time.

Mix and Match

Not sure what your exact needs are?We can come and advise on the most time and cost-efficient use of our services and our collaborators including Regulatory advice services.

Latest News

MHRA Compliance Monitor eligibility

Tracy Moore has been deemed eligible by the MHRA to act as a Compliance Monitor (CM) in MHRA’s pilot compliance monitor programme for GMP/GDP remediation supervision activities.

Join Tracy at PEC, virtually and in Milan!