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Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively. Overall, validation, documentation and quality control were the major cGMP violations.
But the new Joint Guidance on Virtual and Hybrid International Medical Congresses, from the International Federation of PharmaceuticalManufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) is here to plug that gap.
Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch. Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error.
Pharmaceutical wholesalers act as intermediaries between pharmaceuticalmanufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Selecting the best pharmaceutical wholesalers. Temperature control facilities and supply solutions.
Packaging and labelling mix-ups can potentially result in serious health consequences. Accurate labelling of medicines is critical to patient health. Therefore, manufacturers pay particular attention to getting the right medication and strength into the right container with the correct labels and instructions for use.
A validation master plan (VMP) is a strategic document that identifies the elements to validate, the approach to each element, organizational responsibilities, and a strategy for maintaining validation documentation. – General guidance for validation document format. Additional documents included each month.
A pharmaceutical warehouse is responsible for receiving, storing, and releasing incoming goods (including labeling and packaging) and distributing finished products. Therefore, GMP rules ensure that materials are handled and stored properly and that appropriate documentation is maintained. Checkout sample preview s.
The pharmaceutical industry requires specialised and cost-effective commercial packaging solutions to improve efficiency and preserve the integrity of products through the entire supply chain, from primary packaging and labelling to shipping, delivery, storage and distribution to end users.
Table of Contents Importance of sampling in pharmaceutical industry Pharmaceutical sampling procedures are carried out during and at each major processing step during the manufacturing to ensure the highest quality is attained. Pharmaceutical sampling procedures ensure all of the above. as their visual aids.
Additional documents included each month. Adulterated Pharmaceuticals: 396 warnings iii. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. Additional documents included each month. Checkout sample preview s.
Table of Contents Quality risk management principles are already effectively utilized in many areas of pharmaceuticalsmanufacturing business. Additional documents included each month. Is this system used in the creation or verification of product labelling (inserts, outserts, cartons or packaging)? Subscribe Step 1.
The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintain documentation. Why is change control management important in pharmaceuticals? Change control management is a critical and frequently used concept in pharmaceutical industry.
The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintaining documentation. Why is change control management important in pharmaceuticals? Change control management is a critical and frequently used concept in pharmaceutical industry.
Typical flow of samples in a quality control laboratory The quality control laboratory receives samples that are collected randomly at the beginning, middle, and end of manufacturing processes. – Document control records management and archiving systems. Additional documents included each month. Checkout sample preview s.
– Please make sure that proper documentation is maintained and corrective action is undertaken. The FDA subsequently published several guidance documents regarding this matter. Additional documents included each month. Each tablet has the label claim of 100mg (w/w). Additional documents included each month.
In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceuticalmanufacturing. Additional documents included each month. Additional documents included each month. Additional documents included each month. All written and updated by GMP experts.
While focuses on evaluating and establishing supplier reliability for pharmaceuticalmanufacturing companies and compounding pharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients.
Additional documents included each month. Subscribe Corrective action vs preventive action examples In pharmaceuticals, corrective and preventive action (CAPA), is conducted at the implementation stage of most quality concern investigations. . Additional documents included each month. All written and updated by GMP experts.
Additional documents included each month. Additional documents included each month. SOP for instrument calibration: Instrument calibration is important for pharmaceuticalmanufacturing standards. Could you document the process in the instrument calibration register and the instrument history file? Subscribe f.
Additional documents included each month. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. gown qualification).
The FDA sets stringent requirements for operational qualification for critical equipment and systems to ensure the safety and efficacy of pharmaceutical products. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.
The rationale for engaging with certain influencers and digital opinion leaders should be considered and documented. The post New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry appeared first on. Therefore, companies are encouraged to establish a methodology for calculating fair market value rates.
Rework procedure in pharmaceuticalmanufacturing Step-by-step guide Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST A rework procedure is a structured way of correcting quality defects identified in a batch or number of batches of pharmaceutical products.
Proper storage, labelling, and FEFO rotation of incoming materials were highlighted as essential practices. Vendor qualification was presented as a strategic risk management activity, necessitating risk assessment tools, periodic on-site audits, and well-documented SOPs for selection, qualification, and disqualification.
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