Pharmagmps

  It is the time required for the Tablet / Capsule to break into particles, the disintegration test is a measure of the time required under a given set of conditions (Temperature) for a group of tablets/capsules to disintegrate into particles. Cycle of shaft holding the tube basket limit is 29-32 cycles per minutes and distance covered by shaft basket is 50-60 mm and beaker temperature is 35 to 39 º C. Disintegration is to be Performed to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions. 3. What are the Disintegration Time of tablets : Uncoated Tablet 15 min as per BP Uncoated Tablet 30 min as per USP Sugar Coated Tablet 60 min as per BP Film Coated Tablet 30 min as per BP Plain Coated Tablets DT in specific medium for 30 min as per USP Enteric Coated Tablets DT in  simulated gastric fluid (0.1 M HCl) for 1 hr and then in simulated intestinal ...

  The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product. It involves in chemical, physical and some time microbiological testing of a pharmaceutical product. Quality control involves testing of pharmaceutical products against the specifications. The other responsibilities of Quality Control are sampling of Raw & packing material, Testing of raw material, packing material, In process, Finished product& Stability batches, Sampling & testing of water, Calibration of Instruments, Preparation of Specification of Raw, Packing, In process & Finished products, Preparation of Standard Test procedure of Raw, Packing, In process & Finished products and reporting of result after analysis & preparation of COA.

  Returns refer to the process of managing the return of pharmaceutical products from customers or distributors to the manufacturer. The purpose of this process is to ensure that returned products are properly handled and disposed of, and that appropriate actions are taken to prevent recurrence of any quality issues. The steps involved in the returns process typically include the following: 1.     Identification: Returned products are identified and recorded, including the reason for the return and any accompanying documentation. 2.     Inspection: The returned products are inspected to determine their condition and to identify any potential quality issues. 3.     Disposition: Based on the inspection, the returned products are either accepted for reprocessing or disposal, or rejected and destroyed. 4.     Documentation: All actions taken during the returns process are documented, including the reason for th...

  Solvent and material retrieval is a process used to manage the retrieval of solvents and other materials used in the production of pharmaceuticals. The purpose of this process is to ensure that solvents and other materials are handled safely and efficiently, and that they are retrieved and stored in a manner that prevents contamination or degradation. The steps involved in solvent and material retrieval typically include the following: 1.     Retrieval planning: The quantities and types of solvents and materials needed are identified, and a plan is developed for their retrieval. 2.     Retrieval process: Solvents and materials are retrieved from their storage location using appropriate equipment and techniques. 3.     Transport: The solvents and materials are transported to the appropriate production area using dedicated equipment or containers. 4.     Use: The solvents and materials are used in the produ...

  Material rejection and re-issuance is a process used to manage the disposition of materials that have been identified as non-conforming or unsuitable for their intended use. The purpose of this process is to ensure that materials that do not meet the required specifications or quality standards are removed from use and properly disposed of, while ensuring that suitable replacement materials are made available as needed. The steps involved in material rejection and re-issuance typically include the following: 1.     Identification: Materials that do not meet the required specifications or quality standards are identified through inspections, testing, or other means. 2.     Quarantine: The identified materials are placed in quarantine to prevent them from being used or shipped. 3.     Evaluation: The non-conforming materials are evaluated to determine the root cause of the issue and to identify any potential risks associate...

  Change control is a process used to manage changes to a system, process, or product. The purpose of change control is to ensure that changes are made in a controlled manner, and that any potential risks associated with the change are identified and managed appropriately. Change control is an important part of quality management systems, and is used to maintain the integrity and consistency of products and processes. The steps involved in the change control process typically include the following: 1.     Initiation: A change is initiated by a person or department responsible for the system, process, or product. The change request should include a description of the change, the reason for the change, and the potential impact of the change. 2.     Assessment: The change is assessed to determine the potential impact on the system, process, or product. This may involve reviewing documentation, conducting risk assessments, or consulting with su...

  Method validation is the process of demonstrating that an analytical method is reliable, accurate, precise, and suitable for its intended use. The purpose of method validation is to ensure that the results obtained from the method are reliable and can be used with confidence to make critical decisions about the quality of a product or process. Method validation typically involves the following steps: 1.     Method Development: The method is developed to meet the intended purpose and should be optimized for performance. The method should be suitable for the intended use, be specific, accurate, precise, and have appropriate detection and quantitation limits. 2.     Method Validation Plan: A method validation plan is developed that outlines the parameters to be validated. These parameters include selectivity, accuracy, precision, linearity, range, limit of detection, and limit of quantitation. 3.     Validation Protocol: A v...

  Cleaning validation is a process of demonstrating that the cleaning procedures used to remove residues from equipment surfaces are effective and consistent, and that the equipment is suitable for use in the next production batch without cross-contamination or adverse effects on product quality. Cleaning validation typically involves the following steps: 1.     Risk Assessment: A risk assessment is conducted to identify the equipment and areas of the manufacturing process that are most critical for cleaning validation. This assessment helps to identify the types of residues that are likely to remain on the equipment after cleaning and the potential impact on product quality. 2.     Cleaning Procedures: Cleaning procedures are developed and validated to ensure that they are effective in removing the identified residues. The cleaning procedures should be designed to ensure that all areas of the equipment are adequately cleaned and that any r...

  Periodic validation assessment is a process that involves reviewing and evaluating the effectiveness of a validated process, system, or product over time. The goal of periodic validation assessment is to ensure that the validated state of the process, system, or product is maintained throughout its lifecycle and that it continues to meet regulatory requirements. Periodic validation assessments typically involve the following steps: 1.     Review of the Validation Master Plan (VMP): The VMP is reviewed to ensure that it is still relevant and accurately reflects the current state of the process, system, or product. Any changes to the process, system, or product since the last validation assessment are noted. 2.     Review of the Validation Protocol: The validation protocol is reviewed to ensure that it is still appropriate and that the acceptance criteria and testing requirements are still relevant. Any changes to the acceptance criteria or...

  A validation program is a comprehensive plan that outlines the activities, procedures, and responsibilities required to validate a process, product, or system. A validation program is critical to ensuring that products are of high quality and meet regulatory requirements. A validation program typically includes the following components: 1.     Validation Master Plan (VMP): This document outlines the overall strategy and approach for validation activities. The VMP identifies the scope of the validation program, the validation team, the schedule, and the resources required for validation activities. 2.     Risk Assessment: A risk assessment is performed to identify potential hazards and risks associated with the process, product, or system. The risk assessment helps to identify critical process parameters and critical quality attributes, which are used to design the validation protocol. 3.     Validation Protocol: The valid...

  Qualification in the pharmaceutical industry refers to the process of demonstrating that equipment, facilities, utilities, and systems are suitable for their intended use and meet pre-established requirements. Qualification is a critical aspect of ensuring that pharmaceutical products are of high quality and meet regulatory requirements. Qualification typically includes three stages: 1.     Design Qualification (DQ): This stage involves verifying that the design of the equipment or system meets the user's requirements and regulatory standards. 2.     Installation Qualification (IQ): This stage involves verifying that the equipment or system has been installed correctly and meets the manufacturer's specifications. 3.     Operational Qualification (OQ): This stage involves verifying that the equipment or system operates consistently within its defined operating ranges and that it produces the desired results. In addit...

  Critical attributes of an Active Pharmaceutical Ingredient (API) are the physical, chemical, and microbiological properties that are essential for the API to consistently meet its quality attributes and specifications. The critical attributes of an API can vary depending on the specific drug product and the route of administration, but typically include the following: 1.     Identity: The identity of the API must be confirmed through analytical testing to ensure that it is the correct substance. 2.     Purity: The API must be of high purity and free from any impurities that may be harmful or impact the efficacy of the drug product. 3.     Potency: The API must have a consistent level of potency to ensure that the drug product consistently meets its labeled strength. 4.     Stability: The API must have a defined stability profile, meaning it must be able to maintain its quality attributes over its shelf life und...