Tag Archives: System

Essential Elements of a Quality Management System

A good quality management system in a pharmaceutical company can significantly improve the net profit status, high quality medicines for patients, less rework and recall which save more money, good work environment and compliance with local and international regulations.

Quality management is a philosophy. It takes management understanding, commitment and responsibility before introducing and implementing the concept. Once practiced a good quality management system slowly develop or reshape a sustainable organization culture that pays off rapidly.

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

Some basic but essential elements of Quality Assurance as depicted in GMP guidelines and ISO 9001 guideline for pharmaceutical industry can be listed as: the Preparation of standard operating procedures of a complete system maintaining cGMP principles; Preparation and maintenance of effective change control of quality and master file documentation; Recording and management of manufacturing change control; Recording and reporting procedure of Deviations of your systems; Quality concern investigation process; Customer complaint investigation procedure; Quality audit procedures; Vendor assessment, evaluation and certification procedure; Quality control laboratory procedure, Rework procedures for the defective manufactured products; Procedures on training for manufacturing staffs and recall procedure.

Standard operating procedures and manuals should be written in details and referenced to relevant other documents, so a new starter within the organization should be trained easily and expected to perform as per procedure. The result will be a common standard of activities across the organization, good tractability of work flow, deviations and ease of corrective actions as necessary.

Standard Operating Procedure

You should prepare SOPs, forms, templates and manuals, which can be used immediately as the system runs. Forms and templates should be used for record keeping which your people can follow routinely.

Documentations – Classification, Definition and Approval

Quality and Technical/Master file documents to be created to build up a good quality management system for your manufacturing sites. Definition of documents, their classification, approval requirements and retention requirements should be understood.

Quality Documentation Management and Change Control

Procedures to be created on how to generate new quality documents or change control of existing documents, review of quality documents, satellite file management, role of document author, approver, document control officer and satellite file administrator. In this procedures you will also define the numbering systems of different quality documents like audit files, SOPs, forms, templates, manuals, training files, QA agreements, project files etc and their effective archiving system.

Preparation, Maintenance and Change Control of Master Documents

Procedures to be created which will particularly focus on the management of master file documents like specifications, control methods, raw materials, finished goods and packaging specification and test reports, formulation, stability files etc required to generate during the product registration in the market.

Deviation Report System

It is a regulatory requirement to capture all sorts of deviations evolves in your systems in order to maintain the continuous improvement of your processes and systems. Procedures should be created that describes how to categorize the deviations between production, audit, quality improvements, technical deviations, customer complaints and environmental, health and safety deviations. It should also describes the management responsibilities of initiating deviation, capturing data, analysis, investigation, determination of assignable cause/s, generation of management report and initiatives to be taken on corrective and preventative actions.

Vendor Selection and Evaluation

Procedures to be followed during the vendor assessment and vendor evaluation for purchasing of raw materials, critical and non critical packaging components, laboratory supplies, engineering supplies and imported finished goods from the vendor. These instructions are essential for approving prospective vendor.

Vendor Certification

This procedure aims to describe the process by which a vendor may be certified to supply materials or services. This procedure applies to vendors that supply a material or service to be used at any stage of manufacture by operations. Here you will describe the roles of each department in the process to certify an approved vendor.

Product Complaint Procedure

You should have strong procedure to cover the receipt, logging, evaluation, investigation and reporting system of all complaints received from customers for the marketed products. This procedure should contain step by step instruction to be followed during the customer complaint management like numbering of complaint, registering the complaint, evaluation, determination of assignable cause for the complaint deviation, implementation of corrective and preventative actions, trending of complaints and handling of counterfeit products.

Annual Product Review

Some countries require reports as Annual Product Review to sell your products into their market. So you have to create instructions on how to do annual product review, to evaluate data, trends and to identify any preventative or corrective action that would lead to product quality improvements and report them to management.

Rework Procedure

Procedure should contain the step by step instructions to be followed when the rework of an in-process or completed finished good 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 product quality and to ensure their full traceability.

GMP Audits

Procedure should be created to describe the process of planning, performing, reporting and follow-up of different audits for your systems like Internal Quality audit, Vendor audit, Environmental Health and Safety (EHS) audit, EHS workplace inspection, Housekeeping audit.

Evaluation of Batch Documentation and Release for Sale

This procedure should describe the process of collection, evaluation and record of batch related document generated during the production of a batch before an authorized person can release the batch for sale.

GMP Training

Effective GMP related training modules to be created for your manufacturing staffs. Training records and reports have to produce on each employee as justified.

Management and Control of Contract Work

There should have procedure to describe the management and control of contract work provided by the contractors for packaging and finished products for your company as well as control of contract works done by your company on behalf of others.

Quality Concern Investigation Process

Procedure should be made that contains instructions to follow when conducting Investigations collection of data and information, analysis, assigning root cause, determine corrective and preventive actions.

Cleanroom System in Pharmaceuticals

Cleanroom is a part of quality control that intends to enhance the quality of products by limiting the exposure of the products to unwanted particles in the air. Cleanroom in Pharmaceuticals refers to the measure of purity of the air in the room where pharmaceutical products are manufactured or packaged. In simple terms, a cleanroom gives an idea about the size and amount of particulate matters that are present in the air inside the room. In addition, it sets limits for concentration of particles in the room. The concentration of the particles is measured as the number of specific particles per cubic meter of the air. If the particulate concentration goes beyond the limit, the products manufactured in such facilities will not be approved for marketing by the Quality Assurance Department.

According to Federal Standard 209e, cleanroom in pharmaceuticals s are classified according to the amount of concentration of particles in the air. However, the concept of cleanroom does not provide any information about the physical, chemical or radiological characteristics of the particles. Therefore, cleanroom is essentially concerned with the amount of airborne particles. Remember cleanrooms are assigned for industries other than pharmaceuticals. Nonetheless, this classification holds special relevance to the pharmaceutical industries as the regulatory guidelines for manufacture of medications are more stringent than those for others.

A variety of classification systems are used to categorize cleanroom in pharmaceuticals. Each system has its own parameters, and assigns a different class to the room based on the concentration of airborne particles. Some of the common cleanroom standards are governed by:

ISO (International Organization for Standardization)

US FDA (United States Food and Drug Administration)

Federal Standard 209

British Standard 5295

Pharmaceutical Cleanroom Classification

WHO- Good Manufacturing Practice

International Conference on Harmonization Regulations (ICH Q7A)

The documents in the cleanroom standards also have certain sections that guide the use of specific equipments to purify the air according to the industry requirements.

The parameter of cleanroom classification varies on the basis of the formulation of the medication being manufactured. For example, manufacturing facilities for aseptic or parenteral (injectable) products need to have cleaner air compared to those manufacturing topical formulations such as cream, lotion and ointment. Eyes drops or ointments, also called ophthalmic preparations, also need to be sterile just like the parenteral preparations. Hence one can expect similar limits for airborne particulate matters for manufacture of eye preparations. For manufacturing such products, the facilities should also comply with the standard limits for microbial contamination.

There is no doubt over the fact that public health is a very sensitive issue. Medications are used to treat, cure, prevent or diagnose diseases. Therefore they have an explicit effect on the health of the consumers. In essence, medications are more than just chemicals; they can be a poison too. The level of sensitivity increases proportionally when manufacturing injectable or ophthalmic preparations. This is the reason why all the pharmaceutical manufacturing or packaging facilities should strictly comply with the requirements set forth by the governing authority. Hence cleanroom for pharmaceutical is a must.