Quality Assurance - Pharma Egg

Jan62024 by KBS.No Comments

SOP for Management of Documents

A Standard Operating Procedure SOP for Management of Documents is crucial in pharmaceutical manufacturing to ensure the control, organization, and traceability of documents. The following is a general outline for creating an SOP for the Management of Documents Purpose To manage all the regulated / GMP documents SOP for Management of Documents Scope The scope of this document pertains to but not limited to all SOPs, forms, records, templates, protocols, reports and related attached documents prepared at Pharmaceuticals Ltd Responsibilities It is the responsibility of QA to prepare, manage and properly implement this SOP. QA ensures that this SOP is followed in its entirety. It is the responsibility of QA Manager or Designee to review this SOP. It is the responsibility o...

Jan62024 by KBS.No Comments

SOP for cGMP Internal Audit / Self Inspection

Quality Assurance, General SOPS, Production, Quality Control, SOPs

A Standard Operating Procedure SOP for cGMP Internal Audit / Self Inspection in the pharmaceutical industry is vital for ensuring compliance with Good Manufacturing Practice (cGMP) guidelines and maintaining a high level of quality and safety in the manufacturing process. Below is a general outline for creating an SOP for cGMP Internal Audit or Self-Inspection Purpose To describe procedure for planning, executing, reporting and follow up of cGMP internal audit as well as Self Inspection SOP for cGMP Internal Audit / Self Inspection Scope The scope of this document pertains to all regulated departments including, Production, Quality Control, Quality Assurance, Procurement, Engineering, Warehouses and IT department of Pacific Pharmaceuticals Ltd Responsibilities QA Head is respon...

Jan62024 by KBS.No Comments

Out of Specifications (OOS) Handling Procedure

Quality Assurance, General SOPS, SOPs

A Standard Operating Procedure (SOP) for Out of Specifications (OOS) Handling Procedure results in the pharmaceutical industry is crucial for managing deviations from established specifications during the testing or manufacturing of pharmaceutical products. Below is a general outline for creating an SOP for handling Out-of-Specification results. Purpose To describe procedure for reporting, investigating and responding out of specification (OOS) analytical results Out of Specifications (OOS) Handling Procedure Scope The scope of this document pertains to the OOS results in QC for Raw materials / Packaging materials, In Process and Finished Products for releasing at Pharmaceuticals Ltd Responsibilities It is the responsibility of all laboratory personnel working in QC to ensure tha...

Jan62024 by KBS.No Comments

SOP for Change Control in Pharmaceuticals

Quality Assurance, General SOPS, General Topics, SOPs

A Standard Operating Procedure SOP for Change Control in Pharmaceuticals industry is a critical document that outlines the systematic approach for managing and documenting changes to processes, systems, equipment, facilities, or any other aspect that may impact product quality, safety, or efficacy. The following is a general outline for creating an SOP for Change Control in Pharmaceuticals: Purpose To describe procedure for controlling and documenting changes Scope SOP for Change Control in Pharmaceuticals The scope of this document pertains to all major and minor changes related to all approved documents, computerized system, utilities, facilities, equipment, instruments and vendors at www.eggpharma.com Responsibilities It is the responsibility of QA to prepare, manage and p...

Jan32024 by KBS.No Comments

SOP for Environmental Risk Assessment Procedure

Quality Assurance, General SOPS, SOPs

This SOP is to establish a systematic and standardized process for conducting environmental risk assessments to identify, evaluate, and mitigate potential SOP for Environmental Risk Assessment Procedure associated with activities, processes, or products within the organization. 1 PURPOSE of SOP for Environmental Risk Assessment Procedure The purpose of this procedure is to provide a system and instructions to assess and control occupational hazards/aspects of activities, products, and services of www.pharmaegg.com group of companies. This includes to. Evaluate the associated risks and environmental impacts using the risk assessment matrix and prioritize them. Reduce the risks by controlling hazards and environmental aspects using appropriate engineering and administrative control...

Jan32024 by XhaamiNo Comments

ALCOA+ and Data Integrity in Pharmaceutical

Quality Assurance, SOPs

ALCOA+ and Data Integrity in Pharmaceutical is being discussed in this knowledgeable post. Basically, Alcoa is an acronym that stands for Attributable, Legible, Contemporary, Original, and Accurate. Later, Alcoa expanded to Alcoa Plus (Alcoa +), adding a few more concepts that are; Complete, consistent, durable, and available. In addition, the ALCOA + data integrity principles define best practice guidelines and methodologies for good data management, for example, in the pharmaceutical and biotechnology industries. The acronym "ALCOA" defines that the data must be attributable, legible, contemporary, original, and accurate. In addition, the "ALCOA +" guide recommends that the data also be complete, consistent, durable, and available. With the passage of time, ALCOA+ and Data Integrity in ...

Jan32024 by KBS.No Comments

SOP for Operation Calibration and Cleaning of DT Apparatus

Instrument SOP, Quality Assurance, Quality Control, SOPs

If you are looking SOP for Operation Calibration and Cleaning of DT Apparatus then you are landed 0n the right page. In this blog post, we are going to share the process of Operation Calibration and Cleaning of DT Apparatus. It is the unique standard operating procedure Operation Calibration and Cleaning of Disintegration Apparatus equipment. After reading this article you will be able to understand the basic concept of cleaning equipment SOPs. PURPOSE: To lay down the procedure to perform the Operation, Calibration and Cleaning of DT Apparatus. This SOP is to establish guidelines for the proper operation, calibration, and cleaning of the disintegration apparatus to ensure accurate and reliable results in pharmaceutical disintegration testing. SCOPE of SOP for Operation Calibration an...

Jan22024 by KBS.No Comments

SOP for Stability Studies

Quality Assurance, Quality Control, SOPs

A Standard Operating Procedure SOP for Stability Studies in the pharmaceutical industry outlines the step-by-step procedures and guidelines for conducting stability testing on drug products. Stability studies are essential to assess the long-term stability, efficacy, and quality of pharmaceutical products under various environmental conditions. Below is a general outline for an SOP for Stability Studies PURPOSE The purpose of this SOP is to describe the procedure for sample collection, selection of batches, incubation, withdrawal, analysis, reporting, and evaluation, discontinuation, and documentation of stability studies of the drug products. SCOPE of SOP for Stability Studies This SOP is applicable for carrying out stability studies of Finished products manufactured at www.pharmaegg....

Jan22024 by KBS.No Comments

Handling of Deviation in Pharmaceutical Industry

Quality Assurance, SOPs

In the pharmaceutical industry, Handling of Deviation in Pharmaceutical Industry is a crucial aspect of ensuring product quality, patient safety, and regulatory compliance. A deviation is any departure from approved procedures or specifications, and it can occur at various stages of the pharmaceutical manufacturing process. Managing and investigating deviations effectively is essential to prevent recurrence and maintain a high level of product quality. Here are key steps and considerations in handling deviations in the pharmaceutical industry. PURPOSE To define a procedure for handling, recording, investigating and evaluating of planned and unplanned deviations from standard procedure, manufacturing instructions and quality related procedures that impact on product quality. SCOPE of Han...

Jan12024 by KBS.No Comments

SOP for Corrective and Preventive Action CAPA

Quality Assurance, SOPs

The purpose of this SOP for Corrective and Preventive Action CAPA is to establish a systematic and standardized procedure for identifying, implementing, and documenting Corrective and Preventive Actions (CAPA) to address non-conformities, prevent their recurrence, and continually improve processes within pharmaegg.com. PURPOSE of SOP for Corrective and Preventive Action CAPA The purpose of the corrective and preventive action (CAPA) is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing rele...