KBS. - Pharma Egg - Page 11 of 25

Mar152023 by KBS.No Comments

SOP for Metformin Hydrochloride and Sitagliptin Phosphate Tablet Testing by UV and HPLC Method

Sitagliptin + Metformin HCl Tablet is a combination medication used to treat type 2 diabetes. Testing for this medication typically involves a combination of preclinical and clinical studies to evaluate its safety, efficacy, and pharmacokinetics. Preclinical studies involve testing the medication in animal models to determine its toxicity, pharmacokinetics, and pharmacodynamics. These studies help researchers identify any potential safety concerns and determine appropriate dosages for humans' SOP for Metformin Hydrochloride and Sitagliptin Phosphate Tablet Testing by UV and HPLC Method. Clinical studies involve testing the medication in human subjects to evaluate its safety and efficacy. These studies are typically conducted in several phases, starting with small studies on unhealthy...

Mar62023 by KBS.No Comments

SOP for Preparation of Batch Manufacturing Record (BMR)

Quality Assurance, General Topics, SOPs

A batch Manufacturing Record (BMR) is a document that contains all the necessary information related to the manufacturing process of a specific batch of a product. The SOP for Preparation of Batch Manufacturing Record (BMR) is a critical document that provides a comprehensive and detailed account of the manufacturing process and is used to ensure that the batch is manufactured in accordance with established procedures and specifications. Overall, the BMR should be a complete and accurate record of the manufacturing process for a specific batch of a product. It should provide all the information necessary to ensure that the batch is manufactured in accordance with established procedures and meets the required quality standards. PURPOSE The purpose of this SOP is to set forth the procedure...

Mar32023 by KBS.No Comments

SOP for Receipt & Storage of Materials in Pharmaceuticals

General Topics

The responsibility for the proper receipt, storage, and tracking of materials lies with all personnel involved in the process, including but not limited to procurement staff, warehouse staff, and inventory management staff. The SOP for Receipt & Storage of Materials in Pharmaceuticals ultimate accountability for compliance with this SOP rests with the management of the organization. All personnel involved in the receipt, storage, and tracking of materials must be trained on this SOP and must adhere to its provisions. Any updates to this SOP must be communicated to all relevant personnel and training must be provided accordingly. PURPOSE: To lay down a procedure for receiving the raw materials and packaging materials. SCOPE: This SOP is applicable for receipt of Raw and Packing mate...

Mar32023 by KBS.No Comments

SOP for Diclofenac Sodium SR 100mg Tablet Tested UV and HPLC Methods

Testing Methods, General Topics, Product, SOPs

SOP for Diclofenac Sodium SR 100mg Tablet Tested UV and HPLC Methods to determine its purity and quality. Both UV and HPLC methods are widely used in pharmaceutical laboratories to test the quality and purity of diclofenac sodium tablets. These methods are highly accurate and reliable and are used to ensure that the tablets meet the required quality standards. PURPOSE: To describe the procedure for analysis at in-process and finished stage of Diclofenac Sodium SR 100mg Tablet. SCOPE: This SAP gives a detailed outline for the finished product analysis of Diclofenac Sodium SR 100mg Tablet and will cover In process testing activities on a physical, chemical & instrumental basis. RESPONSIBILITY: QC Analyst is responsible for physical / chemical testing and preparing standard analytic...

Mar32023 by KBS.No Comments

SOP for Vonoprazan 10 mg Tablet Testing Procedure

Testing Methods, General Topics, Product, SOPs

Vonoprazan Fumarate is a medication used to treat gastroesophageal reflux disease (GERD) and other gastrointestinal disorders. The SOP for Vonoprazan 10 mg Tablet Testing Procedure should follow the appropriate regulatory guidelines and be validated to ensure the accuracy, precision, and reliability of the results. PURPOSE: To describe the procedure for analysis at in-process and finished stage of Vonoprazan 10 mg Tablet. SCOPE: This SAP gives a detailed outline for the finished product analysis of Vonoprazan 10 mg Tablet and will cover In process testing activities on a physical, chemical & instrumental basis. RESPONSIBILITY: QC Analyst is responsible for physical / chemical testing and preparing standard analytical procedure. It is the responsibility of QC Manager to assist an...

Mar22023 by KBS.No Comments

Trimetazidine Hydrochloride MR 35mg Tablet Testing Procedure SOP

Testing Methods, General Topics, Product, SOPs

Trimetazidine Hydrochloride MR 35 mg Tablet assay testing is a process to determine the potency of the active ingredient in the medication. This Trimetazidine Hydrochloride MR 35mg Tablet Testing Procedure SOP ensures that the medication contains the correct amount of the active ingredient, trimetazidine hydrochloride, which is necessary for it to be effective. PURPOSE: To describe the procedure for analysis at in-process and finished stage of Trimetazidine Hydrochloride MR 35 mg Tablet. SCOPE: This SAP gives a detailed outline for the finished product analysis of Trimetazidine Hydrochloride MR 35 mg Tablet and will cover In process testing activities on a physical, chemical & instrumental basis. RESPONSIBILITY: QC Analyst is responsible for physical / chemical testing and prepar...

Mar22023 by KBS.No Comments

SOP for Testing Itopride 50mg Tablet by UV spectroscopy

Testing Methods, General Topics, Product, SOPs

UV (Ultraviolet) testing is a commonly used technique in the pharmaceutical industry to determine the purity and concentration of a drug substance or a drug product. SOP for Testing Itopride 50mg Tablet by UV spectroscopy is based on the measurement of the absorption of UV light by a compound in a solution. PURPOSE: To describe the procedure for analysis at in-process and finished stage of Itopride 50 mg Tablet. SCOPE: This SAP gives a detailed outline for the finished product analysis of Itopride 50 mg Tablet and will cover In process testing activities on a physical, chemical & instrumental basis. RESPONSIBILITY: QC Analyst is responsible for physical / chemical testing and preparing standard analytical procedure. It is the responsibility of QC Manager to assist and ensure Tes...

Feb272023 by KBS.No Comments

SOP for Amlodipine 5mg/Valsartan 160mg/Hydrochlorothiazide 12.5mg Tablet Assay Testing

Testing Methods, General Topics, Product, SOPs

It is important to follow appropriate safety precautions when handling these drugs and to adhere to the manufacturer's instructions for the assay procedure of SOP for Amlodipine 5mg/Valsartan 160mg/Hydrochlorothiazide 12.5mg Tablet Assay Testing. PURPOSE: To describe the procedure for analysis at the in-process and finished stage of SOP for Amlodipine 5mg/Valsartan 160mg/Hydrochlorothiazide 12.5mg Tablet Assay Testing. SCOPE: This SAP gives a detailed outline for the finished product analysis of SOP for Amlodipine 5mg/Valsartan 160mg/Hydrochlorothiazide 12.5mg Tablet Assay Testing and will cover In process testing activities on physical, chemical & instrumental basis. RESPONSIBILITY: QC Analyst is responsible for physical / chemical testing and preparing standard analytical proce...

Feb272023 by KBS.No Comments

SOP for Tramadol 37.5 mg and Acetaminophen 325 mg tablet Assay Testing

Testing Methods, General Topics, Product, SOPs

Assay testing of a tramadol 37.5 mg and acetaminophen 325 mg tablet would typically involve the quantitative analysis of both active ingredients to determine their content or potency in the tablet. SOP for Tramadol 37.5 mg and Acetaminophen 325 mg tablet Assay Testing is important for ensuring the quality and consistency of the medication, as well as verifying that the tablet contains the expected amount of each active ingredient. Assay testing can be performed using a variety of analytical techniques, including high-performance liquid chromatography (HPLC), gas chromatography (GC), and spectrophotometry. The specific method used will depend on factors such as the properties of the active ingredients and the desired level of sensitivity. During the testing process, a sample of the ta...

Feb232023 by KBS.No Comments

SOP for Issuance, Coding, Reconciliation and Handling of Packing Components

General Topics

Pharmaceutical issuance, coding, reconciliation, and handling of packing components are essential steps in the pharmaceutical manufacturing process. Overall, the issuance, coding, reconciliation, and handling of packing components are critical steps in the pharmaceutical manufacturing process. These steps ensure that all materials/components are tracked, verified, and handled appropriately to ensure product quality, safety, and efficacy. SOP for Issuance, Coding, Reconciliation and Handling of Packing Components is essential to follow established procedures and protocols to ensure that all steps are carried out correctly and that any issues are identified and addressed promptly. OBJECTIVE: This Procedure is applied for issuance & coding of packaging components to achieve the followin...