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PHARMACEUTICAL INDUSTRY :
SOP Upgrade & Consolidation |
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Client: |
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A major generic pharmaceutical company with global operations |
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Problem: |
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Internal audits at a recently acquired site identified significant gaps between SOP content and current plant operations. Many of the site’s 1,020 SOPs were past revision dates or exhibited inaccuracies in content and cross-referencing with other SOPs. Numerous redundancies existed in operations and laboratory procedures. Client teams alone had been unsuccessful in remediating the identified deficiencies within the forecast timeline.
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Approach: |
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A Tunnell Consulting team with extensive expertise in Quality, Laboratory and Manufacturing operations assessed the quality system procedures and a representative sample of all other site SOPs. Findings confirmed that all of the site’s procedures required revision. The consultant team developed with the client a project charter defining governance, expectations and the communication plan to guide revision and consolidation of all the site’s procedures:
- All site SOPs were grouped by activity and each activity was mapped showing scope and links between SOPs. Each area of activity was assessed for risk and prioritized for revision.
- Each consultant was assigned functional representatives from the site to provide input and feedback on new draft procedures, assuring expedited approval and long term site ownership.
- A coordination plan for SOP revision, review and approval, updating of employee training modules, employee training and qualification, and SOP implementation was developed to guide batches of revised SOPs through to implementation. Weekly metrics monitored progress of all steps.
- The SOP governing the SOP system was revised as the first priority, allowing new requirements to guide all subsequent project activity.
- Consultants supported client trainers to ensure that trained and qualified employees were available to meet site production requirements.
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Results: |
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- The 1,020 SOPs were consolidated to 440 updated, independent procedures in a new user and training friendly format.
- SOP training and maintenance requirements were reduced by 57%.
- All employees were up to date on all training requirements.
- All training module requirements were significantly reduced and appropriately defined.
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