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Services

Anchor 1

Audits (Internal)

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Audit / assessment against the clients Pharmaceutical Quality System (PQS), for general PQS activities and GMP

  • Audit schedule generation

  • Preparation – Preparing the audit agenda

  • Conducting – Executing the audit / assessment against the plan, recording any observations, recommendations and good practices

  • Reporting – Generating the appropriate audit report for QA, impacted area and Clients Senior management providing the outcome of the audit / assessment

  • Follow up – Aiding with SMART CAPA generation based on a risk-based approach to ensure that the appropriate actions are taken in line with the risk being observed

  • Risk scoring for frequency of future audits / assessments – Aiding to determine the frequency of when the next audit / assessment should occur based on the outcome of the audit / assessment undertaken

Anchor 2

Audits (External)

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  • Audit / assessment of 3rd Parties used by Client (Questionnaire, Desktop, Virtual or Onsite) for any of the following –

  • PQS activities

  • GMP activities

  • API

  • ATMP

  • Warehouse / Storage

  • Distribution of cold chain and non-cold chain

  • Computer systems

  • Archiving

  • Stability facilities

  • Equipment providers

  • Suppliers of Raw materials

  • Starting materials and intermediates used in manufacturing and testing

  • Audit schedule generation for 3rd parties used by the client – based on a risked based approach.

  • Generation and approval of 3rd party questionnaires

  • Assessment and post execution approval of 3rd Party Questionnaires Preparation – Preparing the audit agenda for 3rd Party audits

  • Conducting – Executing the audit / assessment against the plan, recording any observations, recommendations and good practices

  • Reporting – Generating the appropriate audit report for QA, impacted 3rd party and Clients Senior management providing the outcome of the audit / assessment

  • Issuance of report to 3rd Party

  • Follow up – Aiding with SMART CAPA generation based on a risk-based approach to ensure that the appropriate actions are taken in line with the risk being observed

  • Risk scoring for frequency of future audits / assessments – Aiding to determine the frequency of when the next audit / assessment should occur based on the outcome of the audit / assessment undertaken

Anchor 3

Approved Suppliers list (ASL)

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Generation of the Clients ASL

  • Risked based approach to generate the appropriate ASL for Client

  • QA approval of ASL

Anchor 4

Quality Technical Agreements

(QTA)

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Generation of QTA with Client and 3rd Party

  • Generation of QTA

  • QA approval of QTA

  • Follow up and revision of QTA

Anchor 5

Qualification

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Equipment (Manufacturing and QC testing),

Facility and Computerised systems

  • VMP generation as per Annex 15

  • VMP Approval

  • Protocol generation (DQ, IQ, OQ, PQ or variation of the afore mentioned) pre-execution

  • QA approval of Protocol generation (DQ, IQ, OQ, PQ or variation of the afore mentioned) pre-execution

  • QA post Execution review of Protocol (DQ, IQ, OQ, PQ or variation of the afore mentioned)

  • QA approval of post Execution Protocol (DQ, IQ, OQ, PQ or variation of the afore mentioned)

  • Generation of Validation Summary Reports

  • QA approval of Validation Summary Reports

Pharmaceutical Quality System

(PQS) / Quality Management System (QMS)

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Creation and maintenance of Clients PQS / QMS

  • GAP Analysis against relevant regulations to ensure that PQS / QMS achieved the required standards

  • Generation of Policies

  • Generation of SOPs

  • QA approval of Policies and SOPs

  • Trending of PQS / QMS (deviation, CAPA, audits etc) to ensure compliance

  • Relevant PQS / QMS training

Anchor 6
Anchor 7

Deviations

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Support with generating robust investigations to

assessment the impact of the issue and prevent

reoccurrence

  • Lead deviations used risk-based approach and Root cause analysis tools

  • Generate a comprehensive investigation report with Root cause or probable Root cause

  • QA approval of deviations

  • Deviation training for staff to ensure a consistent approach take for all deviations ensure that Root Cause is identified and where not identified what is the most probable root cause

Anchor 8

CAPA

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Support with generating robust CAPA using

the SMART approach, which could be

generated for any part of the PQS / QMS

  • Generation of SMART CAPA

  • QA approval of CAPA

  • QA close out of CAPA

Anchor 9

Responsible Person for Medicinal Products

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Duties of a Responsible Person for Medicinal Products

  • Eligible to be named Responsible Person (RP) on Licence application and undertake the duties required of a RP

Operational Excellence support

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Support the Client in undertaking process

improvements within their PQS / QMS

  • Depends on activities but can support as a qualified Six Sigma Green Belt

  • Provide Yellow Belt training either in full or in part to support process improvements activities

Anchor 10
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