good quality management system in a pharmaceutical company can be significantly improved net profit for the situation, and high-quality medicines for patients, less rework and remember that save more money, and the environment good work and compliance with local and international laws.
Quality Management is a philosophy. It takes understanding and management commitment and responsibility before the introduction and implementation of this concept. Once exercised good quality management system evolves slowly reshaping sustainable organization that pays off quickly culture.
The first step for the introduction of good quality management system is to know the basic elements of a quality system are clear and the study of where to start. The company's goals must be clearly understood. Policies should be prepared. Then comes the process flow, validating chart process, material flow and organization design. When the good integration between people is achieved, process and material next step is to develop an integrated system in the case of control. Must be no deviation from the control system and the correct analysis.
some basic elements but necessary to ensure the quality as shown in the guidelines GMP and ISO 001 guideline can be listed for the pharmaceutical industry as follows: Setting the standard operating procedures of a complete system to maintain the principles of the boat. Preparation and maintenance of effective change control of the quality of the main file and documentation; the registration and management of change control manufacturing. Recording and reporting systems make deviations; the quality of the investigation concerns the process; clients conducting the investigation of complaints. Quality audit procedures; vendor assessment and evaluation and accreditation procedures; procedure quality control laboratory, and rework procedures for manufacturers of defective products, actions on the training of cadres of manufacturing and make the call.
should be written standard operating procedures and evidence in detail and refer to other relevant documents, so it must be trained in the new beginning within the organization easily and is expected to be performed by the procedure. The result will be a common standard for activities across the organization, Tractability quite a bit of work flow, distractions and ease of corrective actions when necessary.
standard operating procedures
you must set up standard operating procedures, forms and templates and booklets, which can be used immediately for the operation of the system. Forms and templates should be used to save the records that your people can follow routinely.
documentations - classification and definition and approval
quality documentation and technical file / Master to be created to build a good quality of the sites your manufacturing management system. It should be understood the definition and classification of documents, and the requirements of the approval of the retention requirements.
documentation of quality management and change control
procedures to be created on how to generate new documents quality or change the control of the existing documents, review and quality documentation, and management of satellite file, and the role of the document author, corresponding, document control officer and director of the satellite file. In this procedure will also define the numbering different quality documents such as audit files, and standard operating procedures, forms and templates, brochures, training files and agreements QA, project files and other systems, and effective system archiving.
preparation, maintenance and change control of the key documents
procedures to be created which will focus in particular on the management and documentation master file, such as specifications and control methods, raw materials and finished goods and specifications of packaging and test reports, formulation and files stability and required to generate the product in the market during the recording.
deflection system report
it is a regulatory requirement to capture all kinds of distractions evolve your systems in order to maintain the continuous improvement of processes and systems of your own. It should create procedures that describe how to classify deviations between production and auditing, and improving the quality, technical distractions, customer complaints and the environment, health and safety distractions. It should also describe the start of deviation management responsibilities, data capture, analyze, investigate and determine the assignment of the case / s, report generation and management initiatives to be taken with regard to corrective and preventive actions.
vendor selection and evaluation of
and the procedures to be followed during the vendor evaluation and vendor evaluation for the purchase of raw materials and components Packing critical packaging and critical is, laboratory supplies and supplies engineering and imported finished goods from the seller. These instructions are necessary for approval of the prospective seller.
vendor certification
This action is intended to describe the process that may be certified vendor to supply materials or services. This procedure applies to vendors who supply materials or services to be used in any stage of the manufacturing processes. Here we will describe the role of each department in the process of ratification of the approved vendor.
product complaints procedures
You should be strong action to cover the receipt, logging, evaluation, investigation and reporting system for complaints received from customers for products marketed. This procedure must contain step by step instructions to be followed by customer complaints management, such as the number of the complaint, the registration of the complaint and the assessment and determine the cause of a waiver of deviation complaint, and implementation of corrective and preventive actions, heading complaints and dealing with counterfeit products.
[1945001annual] Product Review requireSome countries also reports annual review of products to sell your products in their markets. So you have to create instructions on how to do the annual review of products, to evaluate data and trends and identify any preventive measures or corrective that will lead to improved quality of products and report them to management.
a re-work
procedures must contain the step by step instructions to be followed when re-drafting for in process or completed a good required final . Product identification and traceability The purpose of this procedure is to determine the method used to determine the contribution of all substances that can affect the quality of the product and ensure full traceability.
GMP audit
must create a procedure to describe the planning process, and the performance and preparation of reports and follow-up of various audits of computer systems such as internal quality audit seller environmental, health and safety review (HSE) audit, health and safety at inspection and audit housekeeping work.
evaluate the documents and batch release for Sale
This procedure should describe the collection and evaluation of the process and record the document on the impetus generated during the production of a payment before a person authorized to release the batch for sale.
GMP training
units with effective training relevant GMP to be created for the staff of your manufacturing. Training records according to a new report for the production of each employee as justified.
work of the management and control of contracts
should not be a procedure to describe the management and oversight of contract work provided by contractors, packaging and finished products for your company as well as control over the contract works done by the company on behalf of others.
process quality concerns investigation
shouldprocedures that contain the instructions to be followed when conducting investigations of data and information collection and analysis, and to assign the root causes and identify the corrective and preventive actions.
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