Quality Assurance

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 ...

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...

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...

The purpose of this SOP is to establish a systematic and standardized procedure SOP for Retention and Destruction of Documents within the pharmaegg.com in accordance with legal and regulatory requirements while ensuring the confidentiality, integrity, and availability of information. PURPOSE To define a procedure for document retention, storage, retrieval and their destruction. To ensure that key documents must be retained to provide a traceable, historical record of all activities that has an impact on product quality. Documentation must be readily retrievable in order to meet requirements associated with product investigations, annual product review and formal audits. To define the document retention time for cGMP documentation. SCOPE This sop is applicable in Egg group ...

A Standard Operating Procedure SOP for Internal Audits in Pharmaceuticals is a crucial document that outlines the systematic and standardized approach to conducting internal audits within a pharmaceutical company. Internal audits play a significant role in ensuring compliance with regulatory requirements, identifying areas for improvement, and maintaining the overall quality of pharmaceutical operations. Below is an example outline for an SOP for internal audits in the pharmaceutical industry: OBJECTIVE To define a standardized auditing process for internal audit to evaluate the compliance status to the Quality Management system, GMP and relevant regulatory requirements. REASON To identify strength and opportunity for improvement in operations so minimizing product quality risk. ...

Establishing Standard Operating Procedures Good Data and Record Management Practices (SOP for SOPs) also known as Good Documentation Practices (GDocP), is crucial in maintaining a high standard of data and record management within an organization. The following is a template outline for an SOP for SOPs, emphasizing good data and record management practices. PURPOSE All the Quality Management System and Good Manufacturing Practices (GMP) documents are prepared, properly reviewed and approved by appropriate authorities prior to issue or available at the appropriate locations. All Quality System records related to Quality Management System and GMP are properly identified, filed, indexed, stored, retained and disposed of. Distribution / Circulation/Retrieval Implementation Control. ...

A Standard Operating Procedure SOP for Vendor Qualification in Pharmaceuticals Industry is a crucial document that outlines the steps and criteria for assessing and approving suppliers and vendors. This SOP ensures that the vendors selected meet the necessary quality and regulatory standards to maintain the integrity of pharmaceutical manufacturing processes. Below is a sample outline for a Vendor Qualification SOP: PURPOSE: The purpose of this SOP is to outline the procedure for screening of potential external providers / vendor’s and to assist in evaluation, pre-qualification, selection and reassessment of Raw, Packing and General Materials (Local & Import) supplies by developing enrich vendor database, uphold external provider/vendor information pool to develop partnering/long ter...