Quality Assurance

Creating a Standard Operating Procedure SOP for Pharmaceuticals Record and Data Management is essential to ensure compliance with regulatory requirements and maintain the integrity of critical data. Here's a template to help you develop an SOP tailored to pharmaceuticals. Adjust it according to the specific needs and processes of your pharmaceutical organization. Objective: To assure that records used by pharmaceuticals employees are properly managed. Records include reports, correspondence, diaries, quality records and technical records. Quality records include the following: internal audit reports, management reviews, corrective and preventive actions. Technical records include forms, worksheets, control graphs, inspection reports, and test reports. Scope: This procedure applies to t...

Creating a Standard Operating Procedure for Document and Data Control is crucial for ensuring consistency, accuracy, and compliance in managing organizational information. Here's a template you can use as a starting point. Adjust it based on the specific needs and processes of your organization. Objective This procedure ensure that document within the scope of ISO 9001are controlled so that current version of all document is readily available at the point of application. Scope This procedure will apply to all quality environmental, Lab management system document like, all manual, procedure, work instruction standard and specification format etc. Procedure Document Numbering System  The numbering scheme of all documents will consist of nine numbers. WW/XX/YY/ZZZ First WW show...

Equipment Operational Qualification (SOP) is the process, which establishes through verification and documentation that the equipment is capable of operating within established limits and tolerances. This demonstration of basic performance must involve operational aspects of the equipment that will be routinely used in manufacturing. OBECTIVE: This guideline defines the minimum requirements for facility regarding the Equipment Operational Qualification (SOP) which must be performed following Installation Qualification (IQ) and prior to process, system qualification. SCOPE: All critical equipments will require successful completion of Operational Qualification (OQ). For New Equipment: OQ must be completed prior to manufacture of product for process validation. For existing equi...

SOP for the preparation of Master Formula Record Some basic explanations and instructions were given for preparing various documents required by Good Manufacturing Practice guidelines from WHO and from several regulatory authorities. GMP guidelines include the requirements for documents (individual), documentation (the systems and formats for documents), and documenting (recording) of production and control activities. Most GMP guidelines provide the same or very similar information as the principles of Good Manufacturing Practice are now international in scope. In this guidance document, the requirement for master manufacturing instructions and the requirements as given in different GMP documents, Terms for Master Formula (MF) WHO identifies manufacturing instructions as “Master Formula. ...