Standard Operating Procedure for Documentation and Record-Keeping
1) Purpose
The purpose of this SOP is to establish procedures for the documentation and record-keeping of all activities related to the manufacturing of dental dosage forms, ensuring accuracy, completeness, and compliance with regulatory requirements.
2) Scope
This SOP applies to the documentation and record-keeping activities conducted throughout the entire manufacturing process of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Quality Assurance (QA) Department is responsible for overseeing documentation practices and ensuring compliance with established procedures. All personnel involved in documentation activities are responsible for maintaining accurate and up-to-date records.
4) Procedure
4.1 Documentation Standards
4.1.1 Establish standard formats and templates for documenting all manufacturing activities, including batch records, logbooks, and forms.
4.1.2 Define requirements for document headers, footers, and version control to ensure traceability and document integrity.
4.2 Document Creation and Review
4.2.1 Create documents, such as batch production records and equipment logbooks, according to approved templates and procedures.
4.2.2 Ensure documents are reviewed and approved by authorized personnel before use.
4.3 Data Entry and Recording
4.3.1 Record all relevant data accurately and legibly during manufacturing operations, including process parameters, equipment readings, and personnel observations.
4.3.2 Use approved abbreviations and terminology consistent with company standards.
4.4 Document Control
4.4.1 Maintain document control procedures to manage document distribution, retrieval, and archival.
4.4.2 Ensure that obsolete or superseded documents are promptly removed from circulation and archived as per company policy.
4.5 Record Retention and Retrieval
4.5.1 Establish a record retention schedule specifying the duration and storage conditions for all manufacturing records.
4.5.2 Ensure records are stored securely and can be retrieved promptly for regulatory inspections and internal audits.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Batch Production Records
Equipment Logbooks
Document Control Procedures
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
Regulatory requirements for documentation and record-keeping
8) SOP Version
Version 1.0
