Raw Material - Pharma Egg

Jan292024 by KBS.No Comments

GMP Questionnaire for Excipients

Raw Material, General SOPS, General Topics, Microbiology, Product, Production, Quality Assurance, Quality Control, SOPs, Testing Methods

A Good Manufacturing Practice GMP Questionnaire for Excipients is a tool used to assess and qualify excipient suppliers to ensure compliance with regulatory standards and quality requirements. Part I: To be Completed by Supplier A) Contact Details Name: Address: Postal Code, City: Country: Telephone / fax / E-mail: Contact Person: Is your company the subsidiary of another company or corporation? Yes No If yes, please state name of parent company: Number of local employees: What services do you offer? (enclose a description, if applicable) Is your company certified according to MP (if yes, please enclose certificate) Yes No Part II: To be Completed by Manufacturer Only I confir...

Dec92023 by KBS.No Comments

Acetic Acid Glacial Testing Procedure (SAP)

Raw Material, Quality Control, Testing Methods

The term "SAP" in the context of acetic acid glacial testing likely refers to the "Saponification Value" or "Saponification Acid Value." The Acetic Acid Glacial Testing Procedure (SAP) saponification value is a measure of the average molecular weight of all the fatty acids present in a substance. It is often used in the analysis of fats and oils. Here's a general procedure for determining the saponification value of acetic acid glacial: PURPOSE To ensure the quality of incoming Raw Material. SCOPE It is applicable to the Quality Control Department. RESPONSIBILITY Quality Control Manager Asst. Quality Control Manager Analyst Lab Assistant PROCEDURE Machinery/Equipment/Apparatus Analytical balance Glass Wares Silica crucible Hot plate Desiccator B...

Nov22023 by KBS.No Comments

Material Management Procedures (SOP)

General SOPS, General Topics, Raw Material, SOPs

Standard Operating Procedures (SOPs) are essential documents in any organization, including those in the pharmaceutical industry. Material management SOPs provide guidelines and instructions for the proper handling, storage, tracking, and disposal of materials used in manufacturing processes. Here's a general outline for creating material management procedures (SOP) tailored to your organization's specific needs. The Marketing Division will forward the requirement of local and export products, bonus. Deals samples, and toll-manufactured products on the prescribed Customer order from the Production Manager, 120 days in advance of the finished stock. Requirement for acceptance and approval. The P.M. will approve the customer order and forward it to the Production Division. The produc...

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

How to Test for Titanium Dioxide

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

Titanium dioxide How to Test for Titanium Dioxide (TiO2) is a white, odorless, and tasteless powder that is widely used as a pigment in various products, including pharmaceutical tablets, sunscreen, food, and cosmetics. It is also used as a whitening and brightening agent, as well as an opacifying agent. Titanium dioxide has good durability and is resistant to discoloration and weathering, which makes it suitable for use in a wide range of applications. Some studies have suggested that Titanium dioxide may be harmful if inhaled or ingested in large quantities, but its safety has been widely evaluated and it is generally considered safe for use in personal care and cosmetic products. Purpose To ensure the quality of incoming raw material of Titanium Dioxide. Scope It is applicable for t...