SOPs

Standard Operating Procedures (SOPs) provides end-users with clear instructions on how to work and develop enough to ensure that all end-users can perform their tasks in a consistent and consistent manner. Many processes can be difficult, and it is important to have a balance between too few and too many points. If there are too few points, the end-user will follow their path. On the other hand, too much information and too much detail increase the risk that the end-user will struggle to understand and perform everyday steps, resulting in errors and omissions.

Sops are of different types like Quality Control SOPs, General SOPs, Production SOps, R&D, Regulatory and Validation SOPs etc

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 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...

Feb92023 by KBS.No Comments

Monoethanolamine Raw Material Testing Procedure

Raw Material, Quality Control, SOPs, Testing Methods

Monoethanolamine (MEA) is a colorless liquid used as a cleaning agent and chemical intermediate in various industries. Monoethanolamine Raw Material Testing Procedure its purity and quality, the following analytical methods can be used: pH measurement: Monoethanolamine has a basic pH due to its amine functional group. The pH of a sample can be measured using a pH meter or indicator paper. Titration: This method involves slowly adding a standard acid solution to a sample of MEA until the solution reaches its equivalence point, indicated by a change in pH or color. The volume of acid required to reach the equivalence point can be used to determine the concentration of MEA in the sample. Gas chromatography (GC): This method separates and quantifies the components of a sample using a gas ...

Feb92023 by KBS.No Comments

Lidocaine Hydrochloride Testing Procedure

Raw Material, Quality Control, SOPs, Testing Methods

To test the purity and potency of lidocaine hydrochloride in a pharmaceutical setting, Lidocaine Hydrochloride Testing Procedures several analytical methods. Lidocaine hydrochloride is a local anesthetic commonly used for numbing a specific area of the skin or mucous membranes. To test its purity and potency, the following procedure. Purpose To ensure the quality of incoming raw material of Lidocaine Hydrochloride. Scope It is applicable for the analysis of Lidocaine Hydrochloride in the quality control department. Responsibility Quality Control Manager Assist. Q.C. Manager Q.C Analyst Abbreviations SAP: Standard Analytical Procedure QC: Quality control Procedure Lidocaine Hydrochloride Testing Procedure High-performance liquid chromatography (HPLC): This ...

Feb92023 by KBS.No Comments

How to Test Miglyol (Fractionated Coconut Oil)

Raw Material, Quality Control, SOPs, Testing Methods

Miglyol is a trade name for a type of fractionated coconut oil, which is a highly refined version of coconut oil. It is commonly used as a carrier oil or base oil in the cosmetic and personal care industry due to its stable, long-lasting, and non-greasy properties How to Test Miglyol (Fractionated Coconut Oil). Testing of Miglyol typically involves evaluating its chemical composition, physical properties, and performance in various applications. Some common tests include: Refractive index: This measures the speed at which light passes through a substance and is used to determine its purity. Acid value: This measures the amount of free fatty acids in the oil and is used to determine its freshness and stability. Iodine value: This measures the amount of unsaturation in the oil and is u...

Feb82023 by KBS.No Comments

Propylene Glycol (PG) Testing Procedure

Raw Material, Quality Control, SOPs, Testing Methods

Propylene glycol (PG) is commonly tested using gas chromatography (GC) or high-performance liquid chromatography (HPLC). Propylene Glycol (PG) Testing Procedure and methods use separation techniques to isolate and quantify the PG from a sample, which is then measured using a detector. The choice of method depends on the specific requirements of the test, such as the sample size, level of precision, and required analysis time. Other methods, such as infrared spectroscopy (IR), can also be used but may not be as accurate as GC or HPLC. It's recommended to consult with a specialist or refer to industry-specific standards for the best testing method for a particular application. A step-by-step procedure for testing propylene glycol (PG) using gas chromatography (GC) is as follows: Samp...

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...