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

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...

Feb82023 by KBS.No Comments

Water Sampling for Chemical and Microbial Testing

Quality Control, SOPs, Testing Methods

Water sampling for chemical and microbial testing is a crucial process in ensuring the quality and safety of RO and distilled water. Water Sampling for Chemical and Microbial Testing involves collecting a representative portion of water from a source and analyzing it for various chemical and microbial contaminants. For chemical testing, water samples are analyzed for a range of contaminants, including heavy metals, pesticides, and organic pollutants. The methods used for chemical analysis vary but may include spectrophotometry, chromatography, and mass spectrometry. For microbial testing, water samples are analyzed for the presence of pathogenic microorganisms, such as bacteria, viruses, and parasites. Microbial analysis may involve culturing the water sample in a laboratory or using...

Feb82023 by KBS.No Comments

SOP for Monitoring of Raw Water and Potable Water Quality

Testing Methods, Quality Control, SOPs

Raw water refers to water in its natural state, as it exists in a river, lake, or aquifer, SOP for Monitoring of Raw Water and Potable Water Quality without any treatment or purification. Potable water, on the other hand, is water that is safe for human consumption and meets health and quality standards set by regulatory agencies. Potable water typically undergoes treatment processes, such as filtration, disinfection, and removal of impurities, It is important to note that drinking raw water carries health risks, as it may contain pathogens, contaminants, and other harmful substances that can cause illness or disease. Potable water, on the other hand, is treated and tested to reduce these risks and provide a safe source of drinking water OBJECTIVE To lay down a procedure for monitoring o...

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...

Feb72023 by KBS.No Comments

How to Test Xanthan Gum Raw Material

Raw Material, Quality Control, SOPs

It is important to How to Test Xanthan Gum Raw Materials to follow industry standards, such as those set by the American Oil Chemists' Society (AOCS), when testing xanthan gum. Xanthan Gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with Xanthomonas campestris, then purified by recovery with Isopropyl Alcohol, dried, and milled. How to Test Xanthan Gum Raw Material contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid, and is prepared as sodium, potassium, or calcium salt. It yields NLT 4.2% and NMT 5.0% of carbon dioxide, calculated on the dried basis, corresponding to NLT 91.0% and NMT 108.0% of Xanthan Gum. Purpose To ensure the quality of incoming raw material of Xanthan Gum. Scope It ...

Feb62023 by KBS.No Comments

How to Test Molnupiravir (Method of Analysis)

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

The testing of Molnupiravir raw material can be done through various methods, How to Test Molnupiravir (Method of Analysis) including High-Performance Liquid Chromatography (HPLC): This method is used to determine the purity and potency of the raw material, Nuclear Magnetic Resonance (NMR) Spectroscopy: This method is used to identify the structure of the raw material, Infrared Spectroscopy (IR): This method is used to identify functional groups in the raw material, Mass Spectrometry (MS): This method is used to determine the molecular weight of the raw material, X-Ray Crystallography: This method is used to determine the crystal structure of the raw material. It is important to follow good manufacturing practices (GMP) and standard operating procedures (SOPs) during the testing process...

Feb62023 by KBS.No Comments

How to Test Tapentadol Hydrochloride

Testing Methods, Quality Control, Raw Material, SOPs

Tapentadol, a centrally acting opioid analgesic, is used in the treatment of moderate to severe acute and chronic pain, as well as the management of neuropathic pain associated with diabetic peripheral neuropathy in adults (extended release formulation only). How to Test Tapentadol Hydrochloride Tapentadol functions as an opiate agonist by binding to mu-opioid receptors and inhibiting norepinephrine reuptake. Approximately 97% of the parent drug is metabolised. The main route of tapentadol metabolism is conjugation with glucuronic acid to produce glucuronides. Tapentadol and its metabolites (N-desmethyltapentadol and hydroxyl-tapentadol) are excreted almost entirely through the kidneys, with the conjugated form accounting for approximately 70% of the drug excreted in urine. Tapentadol meta...

Feb62023 by KBS.No Comments

What is Raw Water Testing (Method of Analysis)

Testing Methods, General Topics, Quality Control, SOPs

Reverse osmosis water, or What is Raw Water Testing (Method of Analysis), is water that has undergone a reverse osmosis filtration process. In order to produce pure water, this process includes putting water through a semi-permeable membrane that filters out dissolved salts, minerals, and other contaminants. When water purity is crucial, reverse osmosis is frequently distilled for industrial and commercial applications as well as domestic water filtration systems. Distilled water is water that has through the distillation process, which entails heating water to the boiling point and then condensing the steam back into a liquid form, producing clean water with contaminants and minerals eliminated. This makes distilled water perfect for use in machinery, batteries, and scientific experime...

Feb32023 by KBS.No Comments

Vendor Evaluation Procedure in Pharmaceuticals

Production, General Topics, SOPs

Vendor Evaluation Procedure in Pharmaceuticals qualification is the process of determining whether a vendor can provide the required goods or services to the standards that the purchasing company requires. This article describes in detail how to qualify raw material vendors, packaging vendors, and service providers. This also explains vendor evaluation and re-evaluation. The vendor Evaluation Procedure in Pharmaceuticals assessment is a process that businesses can use to determine whether prospective vendors and suppliers will be able to meet their organizational standards and obligations once they are under contract. The ultimate goal is to secure a portfolio of low-risk, best-in-class vendors and suppliers. PURPOSE: It is intended to provide a system to qualify a vendor /supplie...

Jan312023 by KBS.No Comments

SOP for Process Change Control in Pharmaceuticals

Production, General Topics, Quality Control, SOPs

A formal system by which qualified persons or Subject SOP for Process Change Control in Pharmaceuticals matter Expert of different departments review proposed or actual changes that might affect a validated status of facilities, system, equipment, Document or processes. SCOPE:- This procedure is to be followed while controlling process change in Pharmaceuticals Plant. OBJECTIVE:- To control process variability To operate the process smoothly. RESPONSIBILITY:- Plant Manager Quality Control Manager Quality Assurance Manager Inventory Control Manager Production Manager Maintenance Incharge Critical Process: Following are the critical processes in which change need control in order to control Process variability & for smooth operation: Change of...