Production

Production

Cartridge filter -Integrity testing of SOP on

Cartridge filter -Integrity Testing SOP Objective: To lay down a procedure for integrity testing of the cartridge filter. Scope: This SOP is applicable for integrity testing of cartridge filters in the formulation plant. Responsibility: Production officer / Executive Accountability: The production Head shall be accountable for compliance with SOP. Procedure Pre-Start-up …

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MICROMETER SCREW GAUGE

PROCEDURE FOR CLEANING, OPERATION AND CALIBRATION OF MICROMETER SCREW GAUGE To lay down a procedure for Operation and calibration of micrometer screw. This procedure is applicable for Operation and calibration of micrometer screw. MICROMETER SCREW GAUGE : A Micrometer is a measuring device used for taking the exact measurement of an …

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PROCESS VALIDATION PROTOCOL OF TACROLIMUS CAPSULES

PROCESS VALIDATION PROTOCOL  TACROLIMUS CAPSULES Tacrolimus is administered in conjunction with other medications to inhibit the rejection of a kidney, heart, liver, or lung transplant. This particular medication falls under the category of immunosuppressants, which function by diminishing the efficacy of your body’s immune system. Consequently, this aids in the …

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Production and Process Controls

Production and Process Controls Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process …

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CIP -Cleaning In Place 

CIP -Cleaning In Place  CIP, also known as Cleaning In Place, is a methodical and automated technique used to clean the inner surfaces of manufacturing equipment, including tanks, pipes, and vessels, without the need for disassembly. This approach is extensively utilized in the pharmaceutical sector to remove any remnants of …

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Intervention during Media fill

Intervention during Media fill Media fill is a simulation exercise conducted in aseptic processing areas to evaluate the capability of operators and the manufacturing environment to maintain sterility. The process involves filling sterile growth media into containers using the same equipment and procedures employed in the actual drug manufacturing. It …

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Methods of sterilization

Methods of sterilization Sterilization is necessary for the complete destruction or removal of all microorganisms (including spore-forming and non-spore forming bacteria, viruses, fungi, and protozoa) that could contaminate pharmaceuticals or other materials and thereby constitute a health hazard. Since the achievement of the absolute state of sterility cannot be demonstrated, …

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ACTIVE PHARMA INGREDIENTS/ACTIVE PHARMACEUTICAL INGREDIENTS

ACTIVE PHARMA INGREDIENTS An active pharma ingredients /pharmaceutical ingredient (APIs), also commonly known as a drug substance, is the active ingredient of a biologically active drug or pesticide. The similar term “pharmaceutical active ingredient” is used in medicine, and the term “active substance” can be used to refer to natural …

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QUALIFICATION STUDY FOR VISUAL INSPECTOR

QUALIFICATION STUDY FOR VISUAL INSPECTOR To establish documented evidence that Visual Qualification Protocol is capable to qualify the visual inspector, within the specified quality attributes thereby establishing the Visual Inspectors qualification procedure. Detect and remove units of drug product with predefined defects in a reproducible manner in a controlled process. …

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Stainless steel and types of Stainless steel in Pharma Industries

Stainless steel and types of Stainless steel in Pharma Industries Stainless steel in pharmaceutical applications, such as food and beverage manufacturing, require structural materials to maintain structural integrity (i.e., corrosion resistance and sufficient strength to withstand the conditions of use), as well as inert surfaces (i.e., (low release of contaminants …

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Production Quiz 02

Quiz

Production Quiz 02 Question: What is mottling, and what factors contribute to this defect in tablets? Answer: Mottling is a tablet defect that can be caused by colored drugs (Excipient-related), improper mixing of granular material (Process-related), dirt in the granular material, or the use of oily lubricant, leading to oil …

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Detergents in the Cleaning of Equipment in Pharmaceuticals

Detergents in the Cleaning of Equipment in Pharmaceuticals: Ensuring Effective and Safe Cleaning Practices In the pharmaceutical industry, proper Cleaning of Equipment and maintenance of equipment is crucial to ensure product quality, prevent cross-contamination, and maintain regulatory compliance. Detergents play a vital role in the cleaning process, helping to remove …

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Elements of Good Manufacturing Practices (GMP) in Pharmaceuticals

Elements of Good Manufacturing Practices (GMP) in Pharmaceuticals Good Manufacturing Practices (GMP) is a set of quality assurance guidelines and regulations that ensure the consistent production of safe, effective, and high-quality pharmaceutical products. GMP encompasses various elements that cover all aspects of pharmaceutical manufacturing, including facility design, personnel training, equipment …

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Diethylene Glycol & Ethylene Glycol: Properties, Applications, and Safety Considerations

Diethylene Glycol & Ethylene Glycol: Properties, Applications Diethylene glycol (DEG) and ethylene glycol (EG) are two important chemical compounds widely used in various industries, including pharmaceuticals, automotive, textiles, and antifreeze solutions. These glycols share some similarities in terms of chemical structure and applications, but they also possess distinct properties and …

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Propylene Glycol: Properties, Applications, and Safety Considerations

Propylene Glycol: Properties, Applications, and Safety Considerations Propylene glycol (PG) is a versatile and widely used chemical compound with numerous applications in various industries. It is a colorless, odorless liquid with a viscous consistency. In this blog post, we will explore the properties, applications, safety considerations, and regulatory aspects of …

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Glycerin: Properties, Applications, and Benefits

Glycerin: Properties, Applications, and Benefits Glycerin, also known as glycerol or glycerine, is a versatile and widely used chemical compound with a range of applications in various industries. It is a colorless, odorless, and viscous liquid that has gained popularity due to its unique properties and beneficial characteristics. In this …

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Sorbitol Solution

Sorbitol Solution: Properties, Uses, and Applications Sorbitol solution, also known as sorbitol syrup, is a versatile and widely used sweetener and humectant in the food, pharmaceutical, and cosmetic industries. It is a clear, colorless liquid with a sweet taste and a range of beneficial properties. In this blog post, we …

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Fumigation

Fumigation Fumigation is a method of spraying chemicals (fumigants) in the form of fine mist or vapors in the area (confined space) to reduce the bioburden of the area the Fumigant is a chemical substance which is having bactericidal, fungicidal & sporicidal activity at a defined concentration level. Gaseous decontaminants …

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GEMCITABINE INJECTION

GEMCITABINE INJECTION Gemcitabine is a nucleoside analog and a chemotherapeutic agent. It was originally investigated for its antiviral effects, but it is now used as an anticancer therapy for various cancers. Gemcitabine is a cytidine analog with two fluorine atoms replacing the hydroxyl on the ribose. As a prodrug, gemcitabine …

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Cleaning in Place or CIP systems

Cleaning in Place or CIP systems CIP systems -The cleaning and sanitary aspects of manufacturing drug products are of extreme importance. The pharmaceutical industry must meet high hygienic standards to avoid a product’s degradation and contamination during manufacturing & packing and Area cleaning must be carried out quickly and thoroughly. The …

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