Comparing Multi-National Plant Sites

Scenario: Company X wants to compare SOPs in its pharmaceutical manufacturing facilities in five different countries and ensure that the SOPs at each site are in compliance with corporate policies and consistent with each other.

Solution: Using Dynamic DRUMBEAT^® for Pharmaceuticals Form A, each facility links its GMP-related SOPs to DRUMBEAT^® Concepts. The SOPs listed on Form A are then sorted by DRUMBEAT^® Concept. A Multi-Unit Gap Analysis, Form F, is produced with each of the five facilities listed. Form F indicates which SOPs are available and which are missing at each plant site enabling a standardized comparison of the five facilities. SOPs required by the corporate policies are then screened for quality with a quality attribute of "Consistent with Corporate Policies" added to Dynamic DRUMBEAT^® for Pharmaceuticals Form H.

Results: Plant sites are compared using an established standardized method that is based upon worldwide regulations. SOPs missing from one plant site are obtained from another site and then modified, as appropriate. All SOPs are brought into compliance with corporate policies. Company X is thus better prepared for a regulatory inspection.

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Compliance Assessment

Scenario: Company X wants to assess the level of compliance of its pharmaceutical manufacturing facilities with the FDA’s System Based Inspection program.

Solution: Using Dynamic DRUMBEAT^® for Pharmaceuticals Form A, each facility links its GMP-related SOPs to DRUMBEAT^® Concepts. Checkmarks are entered in the SOP column to indicate that SOPs exists for corresponding DRUMBEAT^® Concepts on the applicable System Based Inspection Report form. A DRUMBEAT^® Rapid Quality Screening is conducted to assess the quality of the SOP. The need to revise the SOP is noted in the comment column of the System Based Inspection Report form. An audit is conducted of the selected system(s) to ensure compliance with the SOP and observations are noted in the comment column of the System Based Inspection Report.

Results: Completed System Based Inspection Report provide overview documentation of the Plant site compliance level and any required actions needed to enhance compliance. Form A and Rapid Quality Screening forms serve as supporting data. Company X is thus better prepared for a regulatory inspection.

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Writing a new SOP

Scenario: As a result of a recent FDA inspection, you need to write an SOP on the Preparation of Master Manufacturing Instructions, but you want to research the regulatory requirements before you write the SOP, and your time is limited.

Solution: Do a search in Dynamic DRUMBEAT^® for Pharmaceuticals for Instructions, by clicking on the binocular icon. When the search displays DRUMBEAT^® Concept 5.02, "Master Processing Instructions", click on the regulatory citations and read the regulatory requirements for Master Manufacturing Instructions, and include the required elements in the SOP.

Results: You write the SOP in less time, with confidence that it is based on worldwide regulatory requirements. Dynamic DRUMBEAT^® for Pharmaceuticals reduced the research time.

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Preparing for a Pre-Approval Inspection

Scenario: You expect a Pre-Approval Inspection in the next month that could involve plant sites X, Y, and Z. Your GMP-related SOPs have been linked at Plants X and Y, but not Z.

Solution: Using Form A, link Plant Z SOPs to DRUMBEAT^® Concepts. While linking Plant Z SOPs, compare Plants X and Y SOPs by using a Multi-Unit Gap Analysis, Form F. When Plant Z SOPs are linked, add Plant Z to the Multi-Unit Gap Analysis. If any plant site is missing an SOP that is available at another Plant Site, a copy should be obtained and modified, as appropriate. Perform a Rapid Quality Screening, Form H, on 100 SOPs from each plant site and DrumKEY™ Analyses on 10 SOPs from each site.

Results: All three plant sites are ready for Pre-Approval Inspection with SOPs of known quality.

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Selecting a Contract Manufacturer

Scenario: You are looking for a new contract manufacturer to produce tablets for you. You have narrowed the list of potential manufacturers to three and plan to conduct only one audit.

Solution: Request each potential contract manufacturer to send you their SOP index listing the SOP Number, Title, and Effective Date. Request that the index be provided in electronic format (preferably Microsoft^® Excel^®), if possible. Using Dynamic DRUMBEAT^® for Pharmaceuticals Form A, link each potential manufacturer’s SOPs to DRUMBEAT® Concepts and then prepare a Single Unit Gap Analyses for each manufacturer and a Multi-Unit Gap Analysis for all of the manufacturers. Compare the results of the Gap Analyses and determine which manufacturer appears to have the required SOPs. Audit the selected manufacturer.

Results: Time and money are saved by only auditing one manufacturer. DRUMBEAT^® Concept linked manufacturer SOPs can also be used to plan the audit.

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GMP Training

Scenario: GMPs require employees to be trained in GMPs and the SOPs related to their job function.

Solution: Link SOPs to DRUMBEAT^® Concepts and use DRUMBEAT^® Concepts to define required training for each job function.

Results: Linking SOPs to DRUMBEAT^® Concept links the SOPs to GMPs as well. Training an individual is simplified because the SOPs are now directly related to the regulations that require them.

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Audit Planning

Scenario: It currently takes several hours to plan an audit and locate the SOPs that will be addressed during the audit.

Solution: Link SOPs to DRUMBEAT^® Concepts and define the concepts that will be covered during the audit. Locate the SOPs that are linked to the DRUMBEAT^® Concepts to be addressed during the audit. Perform a DRUMBEAT^® Quality Screening on the SOPs prior to the audit to find any quality issues. DRUMBEAT^® Concept links can also be used during follow-up on Audit Action Items, if the Action Items are linked to DRUMBEAT^® Concepts.

Results: Audit planning and follow-up time is reduced.

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Linking to FDA and Audit Activities

Scenario: Over the past year, you have collected copies of FDA Inspections at several of your competitors’ facilities, and you want to avoid having the FDA finding the same problems in your plant.

Solution: Create a list of the FDA Observations and link them to DRUMBEAT^® Concepts. Link your SOPs to DRUMBEAT^® Concepts and then compare your SOPs against the DRUMBEAT^® Concepts that were assigned to FDA observations in order to identify vulnerabilities. Correct any deficiencies. Similar practices can be used for audit findings.

Results: You are ready for the FDA.

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