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SOP for Change Control in Pharmaceutical Industry
1.0 OBJECTIVE To lay down a procedure for Change Control. 2.0 SCOPE The SOP is applicable to any change in the documentation and facility required to be carried out to make amendments, rectify errors, improvements, meet regulatory/ statutory/ legal requirements. It shall be applicable to all Departments at XYZ pharm. ... Read More
Quality Plan for a Product or Service Realization
The product and service provision planning process defines the following controls, as appropriate to the product. This plan is sometimes called a quality plan. The quality objectives and regulations The necessary processes, documents and resources The required checks and criteria for product acceptance The records needed Planning also leads into ... Read More
Foundational Principles of ICH GCP
Let’s delve into the fundamental principles that shape the ethical conduct of clinical trials according to ICH Good Clinical Practice (GCP): Ethical Foundation: Clinical trials must align with the ethical principles outlined in the Declaration of Helsinki, ensuring consistency with GCP and relevant regulatory requirements. Balancing Risks and Benefits: Before ... Read More
The Power of Effective Change Control Programs in Pharma Industry
In the fast-evolving landscape of the life sciences industry, the ability to manage change effectively isn’t just beneficial; it’s essential. Change control programs are at the heart of this, ensuring that any changes in processes, equipment, or materials are implemented in a controlled and systematic manner. Why is this important? ... Read More
Key Steps in Uncertainty Determination Based on Empirical and Modeling GUM Approaches
Identify the sources of uncertainty: The first step is to identify and understand the different sources of uncertainty in the measurement process. This can include variability in the measurement instrument, environmental conditions, operator skill, and other factors. Quantify the uncertainty from each source: Once the sources of uncertainty are identified, ... Read More
Biological Filing Process to FDA
Biologic filing is the process of submitting an application to the USFDA to request approval for a new biologic product. Biologics are a type of medicine that is made from living organisms or their products. ๐ง๐๐ฝ๐ฒ๐ ๐ผ๐ณ ๐๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ ๐๐ถ๐น๐ถ๐ป๐ด๐ ๐ง๐ต๐ฒ๐ฟ๐ฒ ๐ฎ๐ฟ๐ฒ ๐๐๐ผ ๐บ๐ฎ๐ถ๐ป ๐๐๐ฝ๐ฒ๐ ๐ผ๐ณ ๐ฏ๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ ๐ณ๐ถ๐น๐ถ๐ป๐ด๐: ๐ง๐ต๐ฒ ๐๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ๐ ๐๐ถ๐ฐ๐ฒ๐ป๐๐ฒ ... Read More
Excel Spreadsheet Validation in Pharmaceutical Industry
What is Excel Spreadsheet? Microsoft Excel is a software program. It is used to create spreadsheets, which are documents in which data is laid out in rows and columns โ like a big table. Excel organizes data in columns and rows and can perform calculations on that data using formulas. ... Read More
How to Create a Validation Master Plan?
Validation master plan (VMP) is a high-level document that summarizes the manufacturerโs overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturerโs qualification and validation work programme and defines details of and timelines for the work to be performed, including a statement of ... Read More
Criteria of Maintaining Audit and Inspection Readiness in Pharmaceutical Industry
To maintain audit and inspection readiness at all times in pharmaceutical industry, following criteria are to be maintained: 1. Clear Communication Channel 2. Document Control and Management 3. Effective Training and Competency Programs 4. Robust Change Control Processes 5. Real-time Monitoring and Data Analytics 6. A Culture of Continuous Improvement ... Read More
References for Good Pharmacy Practice
Introduction to Good Pharmacy Practice (GPP) Patient Care and Counseling Medication Safety and Quality Assurance Pharmaceutical Supply Chain Management Ethical Considerations in Pharmacy Practice Professional Development and Continuing Education Pharmaceutical Legislation and Regulatory Compliance Information Management and Technology in Pharmacy Practice Read also: Compounding Pharmacy Violations Which Put Patients at ... Read More