In Industries, we always face confusion about the “Usage of expired Raw Materials” and “Retesting of expired raw materials” in the formulation of finished drug products. in this article, We will cover some Questions about Expired Raw and API materials in warehousing, as we have tried to explain them in a simple way. What is … Read more
Deviation from any process in pharmaceuticals can lead to a matter of investigation and root cause analysis. the manufacturer or responsible person shall be followed the following steps to do an investigation and root cause analysis by using corrective and preventive action. 1. Investigation/ Title for Root Cause Analysis: Start with the product’s name and … Read more
The procedure is applicable to the general procedure for filling the vaccine in the manufacturing area. Preparation of Primary packaging material for filling: Preparation of Filling Machine parts : Note: If required take the change over to the required format size 2ml, 3ml, or 5 ml format.Wash and prepare filling machine accessories and pack the … Read more
A tray dryer in the pharmaceutical industry is used to dry powders, granules, and other types of materials. It consists of a heated chamber with trays to place materials. The trays are usually stacked one on top of each other, and the drying process is usually done under controlled temperature and humidity conditions. It is … Read more
ICH Q10 guidelines basically mention the effective Pharmaceutical quality system (PQS). the pharmaceutical quality system is based on the ISO quality system including good manufacturing practice (GMP) regulations. Relationship Between ICH Q8, ICH Q9 and ICH Q10 Before the ICH Q10, ICH Q8 (Pharmaceutical development), and ICH Q9 (Quality risk management) were implemented throughout the … Read more
1.0 Purpose: To lay down the procedure for Washing, sterilization of clean room Garments2.0 Aim: This Standard Operating Procedure is applicable to the Washing, sterilization of clean room Garments in pharmaceuticals.3.0 Responsibility: 3.1 The line operator in operation processes shall carry out the operation process of Washing, and sterilization of clean room Garments.3.2 officers/seniors/executives shall … Read more
1.0 Purpose: To lay down the procedure for cleaning and preparation of filling machine accessories for sterilization.2.0 Applicable: This Standard Operating Procedure is applicable for the cleaning and preparation of filling machine accessories for sterilization on the Production Floor.3.0 Responsibility:3.1 The operator shall carry out the cleaning and preparation process.3.2 officers/Executives shall supervise the process.3.3 … Read more
1.0 Purpose: To lay down the procedure for cleaning and preparation and packing of material for sterilization.2.0 Applicable: This Standard Operating Procedure is applicable to the cleaning, preparation, and of packing of material for sterilization on the production floor.3.0 Responsibility: 3.1 The operators who are trained in cleaning processes shall carry out the cleaning process … Read more
1.0 Purpose: The standard procedure; Aseptic Handling, Operation and Aseptic Connection apply to the aseptic technique which refers to the system of working while performing procedures that are to be carried out under sterile conditions. The aim is to prevent microbial contamination while media simulation, manufacturing products, blending procedures, and aseptic connection. 2.0 Applicable: This … Read more
The major difference between HPLC and LCMS is that HPLC uses Non-volatile and Volatile buffers whereas LCMS uses Only volatile buffers. Common Difference between HPLC and LCMS/HPLC-MS HPLC full form is High-Performance Liquid Chromatography. It is a technique that is used to separate and analyze compounds in a mixture using liquid chromatography. It is a … Read more
Equipment capacity means the minimum and max working capacity of any equipment that can be easy to operate with its predefined limit to get higher output. In pharmaceutical Equipment capacity calculation factor depends on the Bulk density of the excipients that are used in the granulation process. Factor affecting the equipment capacity Below are the … Read more
SAT is an inspection at the user’s site after machine/instrument delivery. opposite to SAT, the Factory acceptance test is a Manufacturer site inspection by the user. site acceptance test in pharmaceuticals is done to verify the functioning, operation, and parameters along with manufacturere repersentative. Site Acceptance Protocol Site acceptance test protocol is prepared by the … Read more
Nonconformity finding in pharmaceuticals during Audit is a very crucial stage, where finding non-conformity becomes a hurdle for the organization. Nonconformity may be major or minor types it depends on what type of process is affecting at what level. What is Nonconformity As per ISO 19011 “Nonconformity” means non-fulfillment of a requirement, against ISO 9001 … Read more
The airlocks is a transition space that typically has two doors in series to separate controlled environments such as a cleanroom, lab, operating room, or isolation room from the corridor. What is an airlock? Airlocks are commonly used in the pharmaceutical industry to maintain cleanliness and prevent contamination of the manufacturing environment. In a pharmaceutical … Read more
Lead is a most undesirable impurity in pharma compounds and comes through the use of sulphuric acid, lead-lined apparatus, and glass bottles used for the storage of chemical materials so, we do a Limit Test for Lead to identify the acceptance level of lead in a sample. Limit test for lead Principle The limit test … Read more
The limit test for arsenic is based on the reduction of the arsenic in the arsenic state to the arsenic gas with zinc and hydrochloric acid. The arsenic gas stains the mercuric chloride paper yellow. The paper is dissolved in acid where the arsenic present as an impurity in the sample gets converted into arsenic … Read more