INVESTIGATIONS SOP 

INVESTIGATIONS SOP  This Standard Operating Procedure (SOP) defines the requirements for reporting, documenting, investigating, evaluating, managing, resolving and approving closure of investigations from cGxP, approved specifications and/or procedures. This standard applies to Investigations related to quality related events that occur from cGxP, approved specifications, and/or procedures including but not limited to Protocols, Master Batch Records … Read more

COMPRESSED AIR SYSTEM

COMPRESSED AIR SYSTEM The main aim of the system is to produce and provide the desired quality compressed air as per the designed capacity at designed pressure. The Compressed Air System and quality of the compressed air distributed to all user points must comply with ISO8573, USP, BP and in-house requirements. The Quality refers to … Read more

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 object. It is also known … Read more

SOP ON ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT

SOP ON ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT To lay down a procedure for establishment of Alert Limit and Action Limit. ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT OF SCOPE This SOP is applicable to critical stages of system, analytical test / Microbial test, on-line result regarding water system, process, product and environmental condition … Read more

QUALIFICATION OF CONTRACT TESTING LABORATORY

QUALIFICATION OF CONTRACT TESTING LABORATORY The purpose of this SOP is to describe the procedure for selection, approval, renewal of contract testing laboratory for testing / calibrations. SCOPE OF CONTRACT TESTING LABORATORY: This procedure is applicable for testing done at contract testing laboratory for raw material, intermediate, packaging material, finished product, stability, water analysis, analytical … Read more

HANDLING OF ISOLATES

HANDLING OF ISOLATES This procedure elaborates the systematic approach for the isolation and identification of organism from the routine microbiological testing and monitoring followed by Preparation of cryo vials for isolates. SCOPE HANDLING OF ISOLATES : This SOP is applicable for the characterization of the environmental isolates, Water isolates / product isolates in the microbiology Laboratory. RESPONSIBILITY: … Read more

Operational qualification protocol cum report

Operational qualification Documented verification that the system or subsystem operates as intended overall anticipated operating ranges as per WHO TRS 1019-annex3. The OQ should furnish documented proof that utilities, systems, or equipment are functioning in compliance with operational specifications. The tests should be formulated to exhibit satisfactory performance within the typical operating range, as well … Read more

Design of HVAC systems and components as per TRS 1010

Design of HVAC systems and components Proper design and management of HVAC systems is crucial throughout their entire life cycle. It is important to maintain documentation, such as schematic drawings, to accurately reflect the current state of the system. To ensure the safety and effectiveness of HVAC systems, risk management principles should be applied. This … Read more

GOOD MICROBIOLOGY LABORATORY PRACTICES

GOOD MICROBIOLOGY LABORATORY PRACTICES To provide general guidance on Good laboratory practices in microbiology laboratory consisting of activities that depend on several principles, aseptic techniques, control of media, control of test strains, and control of equipment’s, personnel hygiene, health and garments. SCOPE GOOD MICROBIOLOGY LABORATORY PRACTICES: This SOP is applicable for Microbiology lab. RESPONSIBILITY: Concerned … Read more

PERSONNEL TRAINING, QUALIFICATION,MONITORING AS PER USFDA GUIDELINE

PERSONNEL TRAINING, QUALIFICATION, MONITORING AS PER USFDA GUIDELINE Personnel Training A well-designed, maintained, and operated aseptic process minimizes personnel intervention. As operator activities increase in an aseptic processing operation, the risk to finished product sterility also increases. To ensure the maintenance of product sterility, operators involved in aseptic activities must use aseptic techniques at all … Read more

Critical Area – Class 100 (ISO 5) AS PER USFDA GUIDELINE

Critical Area – Class 100 (ISO 5) AS PER USFDA GUIDELINE A critical area is one in which the sterilized drug product, containers, and closures are exposed to environmental conditions that must be designed to maintain product sterility (§ 211.42(c)(10)). Activities conducted in such areas include manipulations (e.g., aseptic connections, sterile ingredient additions) of sterile … Read more

VALIDATION OF ASEPTIC PROCESSING AS PER USFDA GUIDELINE

VALIDATION OF ASEPTIC PROCESSING AS PER USFDA GUIDELINE Process Simulations To ensure the sterility of products purporting to be sterile, sterilization, aseptic filling, and closing operations must be adequately validated (§ 211.113). The goal of even the most effective sterilization processes can fail to achieve their objective if the sterilized components of a product, such … Read more

High-Efficiency Particulate Air (HEPA) As Per USFDA GUIDELINE

Air Filtration – High-Efficiency Particulate Air (HEPA) As Per USFDA GUIDELINE HEPA filter integrity should be maintained to ensure aseptic conditions. Leak testing should be performed at installation to detect integrity breaches around the sealing gaskets, through the frames, or at various points on the filter media. Thereafter, leak tests should be performed at suitable … Read more

Air Filtration by Membrane AS PER USFDA GUIDELINE

Air Filtration by Membrane AS PER USFDA GUIDELINE Air Filtration by Membrane – A compressed gas should pass for purity test to ensure it is free from oil and meets the required standards for microbiological and particle quality after filter. The quality of the compressed gas should be at least equal to the air quality … Read more

Alcoa++

Alcoa++ In a world where data plays a crucial role in decision-making and technological advancements shape various industries, the significance of data integrity cannot be emphasized enough. Alcoa, a company renowned for its commitment to excellence, extends the principles of Alcoa Plus Plus beyond aluminum production to prioritize data integrity as a fundamental aspect of … Read more

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 the previous product, cleaning agents, … Read more

GLP-GOOD LABORATORY PRACTICES AND REQUIREMENTS OF PREMISES AND EQUIPMENTS

GLP-GOOD LABORATORY PRACTICES AND REQUIREMENTS OF PREMISES AND EQUIPMENTS General Requirements OF GLP :- The laboratory or the organization it belongs to must have legal authorization to operate and be held accountable under the law. The management is responsible for ensuring that the laboratory conducts its testing, calibration, validation, and other technical activities in compliance with Good … Read more

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, the sterility of a pharmaceutical … Read more

Introduction of New Product in Facility

Introduction of New Product in Facility The implementation of a novel product in a pharmaceutical industries necessitates a Carefully planned & organized sequence of actions to guarantee a seamless and adheres to regulations and guidelines. Below is an exhaustive compilation of activities that should be taken into account: New Product Project Planning: Create a project plan … Read more

Emulsion & Role of Emulsifying Agents

Emulsion & Role of Emulsifying Agents Emulsion refers to a colloidal dispersion where two liquids that do not mix are blended uniformly. It comprises small droplets of one liquid dispersed in another liquid. The stability of emulsions is of utmost importance in various industries such as food, pharmaceuticals, and cosmetics. To ensure stability, emulsifying agents … Read more