General Topics - Pharma Egg

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...

Feb232023 by KBS.No Comments

SOP for Procedure for Process Change Control

Quality Assurance, General Topics, SOPs

Process change control is a crucial part of pharmaceutical manufacturing operations as it ensures that any modifications made to the manufacturing process are evaluated and documented to ensure product quality, safety, and efficacy. SOP for Procedure for Process Change Control is essential to follow a well-defined change control process in the pharmaceutical industry to ensure that any modifications made to the manufacturing process are thoroughly evaluated, documented, and controlled to ensure product quality, safety, and efficacy. PURPOSE: To control process variability To operate the process smoothly SCOPE: This procedure is to be followed while controlling process change in the production department. RESPONSIBILITY: Chief Executive Officer Quality Control Manager Quali...

Feb82023 by KBS.No Comments

SOP for Povidone (PVP) Raw Material Powder Testing

Raw Material, General Topics, Quality Control, SOPs, Testing Methods

Povidone (PVP) is a water-soluble polymer commonly used as a binder, dispersant, or viscosity enhancer in pharmaceuticals. SOP for Povidone (PVP) Raw Material Powder Testing of PVP RM powder typically involves verifying its physical characteristics (e.g. particle size, color, odor) and evaluating its chemical properties (e.g. assay, impurities, dissolution). These tests help to ensure the quality and consistency of the PVP RM powder, and can also help to identify any potential contaminants that might affect the product's safety or efficacy. The specific tests performed will depend on the intended use of the PVP RM powder and may vary based on the manufacturer and regulatory requirements. A Standard Operating Procedure (SOP) is a written document that outlines the steps involved in a labora...

Feb82023 by KBS.No Comments

SOP for Raw Material Sampling in Pharmaceuticals

Raw Material, General Topics, Quality Control, SOPs

Raw material sampling in the pharmaceutical or SOP for Raw Material Sampling in Pharmaceuticals industry refers to the process of taking a representative sample of a raw material used in the manufacture of drugs to determine its quality and identity. This is important to ensure that the raw material meets the specifications set out in the quality control standards and that it is suitable for use in the manufacture of safe and effective drug products. Raw material sampling is typically performed at the point of receipt, and the samples are analyzed using various analytical techniques such as chromatography, spectroscopy, and microscopy to ensure that the raw material is free from impurities and contaminants. Raw material sampling in the pharmaceutical industry involves taking a represent...

Feb82023 by KBS.No Comments

Standard Operating Procedure on Sop in a Pharmaceutical Industry

General Topics, Quality Assurance, Quality Control, SOPs

A Standard Operating Procedure on Sop in a Pharmaceutical Industry is a detailed, written instruction that outlines the steps required to perform a specific activity within a pharmaceutical industry. It provides a standard and consistent approach to processes, ensuring that they are performed accurately, consistently, and in compliance with regulatory requirements. In the pharmaceutical industry, SOPs are critical to ensure the quality and safety of drug products, as well as to ensure compliance with regulatory requirements. Each SOP should include a clear description of the steps involved, the personnel responsible for each step, and the equipment and materials required. It should also include clear instructions on how to perform each step, as well as on how to document and record t...

Feb82023 by KBS.No Comments

Risk Management in Pharmaceuticals

SOPs, General Topics, Quality Assurance, Quality Control

Risk management in pharmaceuticals is the systematic process of identifying, assessing, and prioritizing potential risks associated with the development, production, and distribution of drugs, and implementing measures to mitigate these risks. This involves identifying and assessing the potential risks associated with each stage of the drug development process, from the initial discovery and development of new compounds to the post-market monitoring of drugs once they are on the market. Risk mitigation strategies may include changes to the drug's formulation, manufacturing processes, labeling, or distribution methods, as well as increased monitoring and clinical testing. The goal of risk management in pharmaceuticals is to ensure that drugs are safe and effective for patients, while also b...