MAVERICKS ASSOCIATION

Author: Alvina

  • Sampling Plan in Cleaning Validation

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    Sampling Plan in Cleaning Validation: Ensuring Effective Contamination Control Cleaning validation is a critical process in the pharmaceutical and healthcare industries to ensure that equipment, surfaces, and facilities are effectively cleaned and free from product residues, contaminants, and microbial agents. A well-designed sampling plan is an integral part of the cleaning validation process, allowing for…

  • Data Integrity: Ensuring Trustworthy and Reliable Information in the Digital Age

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    Data Integrity: Ensuring Trustworthy and Reliable Information in the Digital Age In today’s digital era, data has become a cornerstone of modern organizations across various industries. However, Data Integrity, i.e., its accuracy, completeness, consistency, and reliability, is paramount to making informed business decisions, maintaining regulatory compliance, and safeguarding customer trust. This blog post delves into…

  • Sorbitol, Glycerine, and Propylene Glycol in Pharmaceuticals

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    New Updates on Sorbitol, Glycerine, and Propylene Glycol in Pharmaceuticals: Applications, Safety, and Regulatory Considerations Sorbitol, glycerine, and propylene glycol are widely used in the pharmaceutical industry for various purposes, including as excipients, solvents, humectants, and sweeteners, These substances play essential roles in pharmaceutical formulations, contributing to product stability, texture, and palatability. This blog post…

  • Dossier -Pharmaceutical Product

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    Dossier -Pharmaceutical Product In the pharmaceutical industry, a well-prepared product dossier is crucial for obtaining regulatory approval and ensuring the safety, efficacy, and quality of a drug. This comprehensive guide will walk you through the essential steps involved in preparing a pharmaceutical product dossier, highlighting key considerations and best practices. Understand Regulatory Requirements The first…

  • HANDLING, MANAGEMENT, AND INVESTIGATION OF DEVIATION

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    HANDLING, MANAGEMENT, AND INVESTIGATION OF DEVIATION PURPOSE To describe the procedure for reporting, investigating, and handling deviations that occur during any stage of processing & testing, in any quality documents, reports, or records, the handling of event that occurs during any of the activities associated with manufacturing, processing, packing operation or holding of a drug…

  • Operating and cleaning procedure of the trolley

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    Operating and cleaning procedure of the trolley To define the procedure for use (operating and cleaning procedure) of the trolley. SCOPE: This SOP is applicable to all sections in the formulation. RESPONSIBILITY: Production Supervisor – Implementation of SOP Workmen – To operate and clean the trolley as per SOP. ACCOUNTABILITY: Production HEAD PROCEDURE: The following type of Trolleys…

  • SAMPLING, RELEASE, AND RETENTION SAMPLES OF RAW MATERIAL

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    SAMPLING, RELEASE, AND RETENTION OF SAMPLES OF RAW MATERIAL PROCEDURE SAFETY/PRECAUTION During sampling RLAF should be ON before 15 minutes. Keep RLAF ‘‘ON’’ during sampling activity. Always take one or more than one containers of one batch at a time inside the sampling booth as per feasibility for sampling. Switch OFF the RLAF after completion…

  • Cleaning procedure of housekeeping items

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    Cleaning procedure of housekeeping items  OBJECTIVE: To establish a cleaning procedure for housekeeping items. SCOPE: This SOP is applicable to all sections in the formulation. RESPONSIBILITY: Production Supervisor – Implementation of SOP. Workmen / Housekeepers – To clean the housekeeping items as per SOP. ACCOUNTABILITY: Production HEAD PROCEDURE: Cleaning: Housekeeping items include: Moping cloth & its handle,…

  • Monthly work in process report

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    Monthly work in process report OBJECTIVE: To establish a procedure for the preparation of monthly work-in-process reports & monthly stock of packing material on the shop floor. SCOPE: This SOP is applicable to all areas of the formulation. RESPONSIBILITY:  Department in charge – Implementation of SOP & Documentation. Production Supervisor – To check & prepare a statement as per SOP.…

  • Operating and cleaning procedure of trolley

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    Operating and cleaning procedure of the trolley OBJECTIVE: To define the procedure for use (operating and cleaning procedure) of the trolley. SCOPE: This SOP is applicable to all sections in the formulation. RESPONSIBILITY: Production Supervisor: Implementation of SOP. Workmen: To operate and clean the trolley as per SOP. ACCOUNTABILITY: Production HEAD PROCEDURE: The following type of Trolleys…

  • Process Selection and Control

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    Process Selection and Control The production of sterile products is profoundly impacted both by formulation and the selection of primary packaging components. Design parameters for a facility and selection of appropriate manufacturing technologies for the product require that the formulation process and packaging components be chosen and evaluated in advance. Formulation and Compounding Primary Packaging…

  • TABLET PRESS

    TABLET PRESS

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    TABLET PRESS Tablet Compression Machine, also known as Tablet Press. Series of cams, punches, and rollers make up Rotary Tablet Press, sometimes mechanical devices are added for filling and ejecting Tablets. All the spares are precisely crafted and made from high-quality materials which are corrosion-free and robust. Whether you want to produce vitamin Tablets or…

  • Three-bucket mopping trolley

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    Three-bucket mopping trolley To provide a written procedure for the operation, cleaning & precaution of three bucket mopping trolleys. DEFINITIONS Aseptic Area: a room or special area within the clean room designed, constructed, serviced & used with the intention of preventing microbial contamination of the product during production because it can’t support the growth of…

  • BRIEF DESCRIPTION OF HVAC (HEATING, VENTILATION AND AIR CONDITIONING SYSTEMS)

    BRIEF DESCRIPTION OF HVAC (HEATING, VENTILATION AND AIR CONDITIONING SYSTEMS)

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    BRIEF DESCRIPTION OF HVAC (HEATING, VENTILATION, AND AIR CONDITIONING SYSTEMS) To avoid cross-contamination and to maintain relative humidity, temperature, and Pressure Difference in the manufacturing areas with Air handling Units Provided in the manufacturing, warehouse, quality control, and microbiology section. Temperature and humidity are controlled and maintained within the limits as per the requirement of…

  • Personnel Hygiene Requirement

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    Personnel Hygiene Requirement All employees are advised and encouraged to observe the following guidelines: – [a]     To wash hands properly. [b]     To keep hair short and clean at all times. Combing hair is strictly prohibited in GMP areas. [c]     To keep the nails well-trimmed and cleaned. [d]     Not to eat or drink in the manufacturing…

  • Health Requirements for Personnel Engaged in Production

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    Health Requirements for Personnel Engaged in Production The personnel and Administration department is responsible for maintaining the health requirements of all employees. Pre-employment medical examination All the employees directly or indirectly associated with production activities are undergoes medical examinations before they join the company. A candidate to be employed in manufacturing areas should be free…

  • Identification of training needs

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    Identification of training needs The training needs of employees are identified by qualification, past experience, personal discussion, and on the basis of day-to-day observation by the respective department heads, with respect to their job responsibility. On the basis of these identified training needs, a complete training program is planned. For all new recruitment, a set…

  • RESPONSIBILITY OF QUALITY ASSURANCE FUNCTIONS

    RESPONSIBILITY OF QUALITY ASSURANCE FUNCTIONS

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    RESPONSIBILITY OF QUALITY ASSURANCE FUNCTIONS: Quality assurance can be defined as “part of quality management focused on providing confidence that quality requirements will be fulfilled.” The confidence provided by quality assurance is twofold—internally to management and externally to customers, government agencies, regulators, certifiers, and third parties. An alternate definition is “all the planned and systematic activities implemented within the quality system…

  • Vacuum leak test machine

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    Vacuum leak test machine To provide a written procedure for cleaning, operation, monitoring & precaution of vacuum leak test machine. Vacuum leak test: A vacuum leak test is the process to detect the weak part of the body or joints in the container by means of a vacuum. This process is carried out in the…

  • SOP List Small Volume Parenteral

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    SOP List Small Volume Parenteral General planning and works instruction in production Entry & Exit Procedure for Clean Area Manufacturing Room Entry & Exit Procedure for Clean Area Filling Room Clean & Sanitization of Classified/Clean area Procedure for Packing Material Reconciliation and its Destruction  Area cleaning and Sanitization Disinfectant  solution preparation, consumption & Destruction for…