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What is Disintegration Test

  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 ยบ 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 ...
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What is Quality Control

  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.
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Returns

  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...
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Solvent and Material Retrieval

  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...
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Material Rejection and Re-issuance

  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...
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Change Control

  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...
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Method Validation

  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...
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