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Audits and Reports
Procedure on how to perform audits and requirements for subsequent reports.
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Batch Record Review
Procedure on how to review batch / production records.
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Corporate QA Audits
Procedure identifying the responsibilities and requirements for performing QA audits of operations related to the items that the firm/function oversees. This audit procedure is from a higher "corporate" level.
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Corrective and Preventative Actions (CAPA)
Procedure on corrective and preventative actions (CAPA). Covers how to investigate for root cause, tracking of implementation, and closure.
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Creation of Forms
Procedure on how to write and the requirements for forms used with SOPs and other controlled systems.
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Creation of Installation Qualification Protocols
Procedure on how to write and the requirements for equipment installation qualification protocols (IQ).
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Creation of Item Specifications
Procedure on how to write and the requirements for Item Specifications.
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Creation of List Documents
Procedure on how to write and the requirements for simple list documents.
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Creation of Logs and Logbooks
Procedure on how to write and the requirements for logs and logbooks used to support controlled systems.
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Creation of Operational Qualification Protocols
Procedure on how to write and the requirements for equipment operational qualification protocols (OQ).
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Creation of Performance Qualification Protocols
Procedure on how to write and the requirements for equipment performance qualification protocols (PQ).
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Creation of Standard Operating Procedures
Procedure on how to write and the requirements for standard operating procedures.
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Customer Complaint Processing
Procedure on how to receive, handle, and investigate customer complaints.
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Deviation Reporting System
Procedure for handling deviations (also known as non-conformances) to controlled procedures.
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Document Change Control
Procedure on document change control. Required to review and approve controlled documents.
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GMP Protocols and Reports
Procedure on how to write and the requirements for GMP-level protocols and reports.
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Laboratory Notebook Issuance
Standard Operating Procedure (SOP) describing the issuance and tracking of laboratory notebooks.
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Management Reporting and Quality Review
Procedure on management reporting and quality review. Required by FDA.
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Master Batch Records and Batch Record Issuance
Procedure on how to write and the requirements for master batch records (production records) as well as the issuance of executable copies.
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Medical Device Reporting
Procedure on reporting to the FDA for adverse events for medical devices. Required by the FDA for medical device manufacturers.
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Personnel Qualifications
Procedure on how to keep records of personnel qualifications and training.
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Quality Assurance Disposition Process
Procedure on how to disposition / release products and processes for various uses, including commercial release.
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Regulatory Inspections
Procedure and policy on how handle regulatory inspections. Includes the requirements for responses to regulatory agencies.
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Signature Log (FREE SOP!)
Procedure for official record of signatures and initials for employees. This document is provided ABSOLUTELY FREE to try our services!
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Technical Change Control
Procedure on technical change control. This manages technical (not simply one document) changes from an overview standpoint.
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Third Party Change Control Oversight
This document describes the procedures and requirements for the oversight of changes and the maintaining of adequate historical records of such changes from Third Party Manufacturers (TPMs) where API intermediates and API are manufactured and/or tested.
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