A good quality management system in a pharmaceutical company can significantly improve bottom line status, high quality drugs for patients, less remanufacturing and recalls, saving more money, good work environment and compliance with regulations. local and international regulations.

Quality management is a philosophy. Management understanding, commitment and responsibility is needed before the concept is introduced and implemented. Once a good quality management system is practiced, a sustainable organizational culture is slowly developed or reshaped and quickly pays for itself.

The initial step to introduce good quality management in a system is to know the essential elements of the quality system and clearly study where to start. The objectives of the company must be clearly understood. Policies must be prepared. Then comes the design of the process flow, validating the process, material flow and organization chart. When a good integration between people, processes and materials is achieved, the next step is to put the integrated system in a state of control. Any deviation from the controlled system must be analyzed and corrected.

Some basic but essential elements of Quality Assurance, as described in the GMP guidelines and the ISO 9001 standard for the pharmaceutical industry, can be listed as: the preparation of standard operating procedures of a complete system that maintains the cGMP principles; Preparation and maintenance of effective quality change control and master file documentation; Registration and management of manufacturing change control; Procedure for registration and reporting of deviations from their systems; Quality problem investigation process; Client complaint investigation procedure; quality audit procedures; Supplier assessment, evaluation and certification procedure; Quality control laboratory procedure, Rework procedures for defective manufactured products; Manufacturing personnel training procedures and recovery procedure.

Standard operating procedures and manuals should be written in detail and reference other relevant documents, so a new member of the organization should be easily trained and expected to perform according to procedure. The result will be a common standard of activities across the organization, good work flow manageability, deviations, and ease of corrective action as needed.

Standard Operating Procedure

You need to prepare SOPs, forms, templates and manuals, which can be used immediately as the system is running. Record-keeping forms and templates should be used that your people can follow on a routine basis.

Documentation – Classification, Definition and Approval

Master/technical and quality file documents to be created to build a good quality management system for your manufacturing sites. The definition of documents, their classification, approval requirements, and retention requirements must be understood.

Management of quality documentation and change control

Procedures to be created on how to generate new quality documents or change control of existing documents, quality document review, satellite file management, role of document author, approver, document control officer and satellite file manager. In these procedures you will also define the numbering systems for different quality documents such as audit files, SOPs, forms, templates, manuals, training files, quality control agreements, project files, etc. and its effective filing system.

Preparation, Maintenance and Change Control of Master Documents

Procedures will be created that will particularly focus on the management of master file documents such as specifications, control methods, raw materials, finished products and packaging specifications and test reports, formulation, stability files, etc. necessary to generate during the registration of the product in the market.

Deviation Report System

It is a regulatory requirement to capture all kinds of deviations in your systems to maintain continuous improvement of your processes and systems. Procedures should be created that describe how to categorize deviations between production, audit, quality improvements, technical deviations, customer complaints, and environmental, health and safety deviations. It should also describe the management responsibilities of initiating deviations, capturing data, analysis, investigation, determination of assignable causes, generation of management reports and initiatives to be taken on corrective and preventive actions.

Selection and evaluation of suppliers

Procedures to be followed during supplier evaluation and supplier evaluation for the purchase of raw materials, critical and non-critical packaging components, laboratory supplies, engineering supplies, and finished goods imported from the supplier. These instructions are essential for the approval of potential providers.

Supplier certification

This procedure is intended to describe the process by which a supplier can be certified to supply materials or services. This procedure applies to suppliers who supply a material or service to be used at any stage of manufacturing operations. Here you will describe the roles of each department in the process of certifying an approved provider.

Product claim procedure

You must have a solid procedure to cover the system for receiving, registering, evaluating, investigating and reporting all complaints received from customers for the products marketed. This procedure must contain step-by-step instructions to be followed during the management of customer complaints, such as numbering of complaints, complaint registration, evaluation, determination of the assignable cause for the deviation of the complaint, implementation of corrective and preventive actions, trends of complaints and counterfeit handling. products

Annual Product Review

Some countries require reports like Annual Product Review to sell their products in their market. Therefore, you need to create instructions on how to conduct an annual product review, evaluate data, trends, and identify any preventive or corrective actions that lead to improvements in product quality and report them to management.

Rework Procedure

The procedure should contain the step-by-step instructions to be followed when rework of a finished or in-process finished product is required. Product Identification and Traceability The purpose of this procedure is to define the method used for the identification of all contributing materials that could affect the quality of the product and ensure its complete traceability.

GMP Audits

A procedure should be created to describe the process of planning, conducting, reporting, and tracking different audits for your systems, such as internal quality audit, supplier audit, environmental health and safety (EHS) audit, EHS on-site inspection of work, cleaning audit.

Evaluation of Batch Documentation and Release for Sale

This procedure should describe the process of collecting, evaluating and registering the document related to the lot generated during the production of a lot before an authorized person can release the lot for sale.

BPM Training

Effective GMP related training modules will be created for your manufacturing staff. Training records and reports to be produced on each employee are justified.

Management and Control of Contract Works

There should be a procedure to describe the management and control of contract work provided by contractors for packaging and finished goods for your company, as well as the control of contract work performed by your company on behalf of others.

Quality Problem Investigation Process

A procedure must be made that contains instructions to follow when carrying out investigations, data and information collection, analysis, root cause assignment, determination of corrective and preventive actions.