Quality control is an essential operation for every pharmaceutical company. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation.
It is that part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & relevant tests are performed & the product is released for use only after ascertaining it’s quality.
Main responsibilities in quality control in our company include:
Quality control in our company is done in the following cases:
Raw materials and API:
The techniques used include IR Spectroscopy, assay( HPLC and titration), physical tests, etc.
The various packaging components which are in contact with the drug are tested. The tests include appearance, loss on drying, spectroscopy, etc.
The techniques include HPLC, Assay, Dissolution, Content uniformity, etc.
QUALITY CONTROL OF VARIATION:
The quality of any drug given by us is always assured and we have the sole responsibility on it, that it does not show any variation from the prescribed standards of quality.
We ensure that quality variation does not occur due to any mistake during the whole process, i.e, from the reception of raw material up to final product in the packaged form.
Controlling each and every step of the processing can control variations, keeping this in mind we divide it into,
- Material control
- Manufacturing practice control
- Packaging control
- Distribution control
- This we immediately start just after the reception of the material. Most of the materials that we receive are active substances, excipients, packaging and printing materials which we receive from the suppliers.
- We have adequate established system for receiving, testing and storage of all these supplied items.
- We do maintain a complete record of all the procedures and tests.
- The material is stored in a proper way either they are arranged alphabetically or they are differentiated depending upon physical nature.
- Then samples are taken for laboratory testing.
- In case of active constituents, percentage purity, adulteration, expiry date, lot number, exact packing etc is checked.
- In case of printing and packaging material especially the color of label, weight of label and cartons and damage etc is checked.
- If the material is up to the mark, then a label (Passed) is pasted on it and it is placed at its proper place. On the other hand, if it is substandard, then it is kept in “Rejected Area” and sent back to the supplier.
Manufacturing Practice Control:
- All the workers are properly check all the process in different stages and been monitored by highly educated and experienced persons who are not only well qualified but experienced as well.
- We do ensure proper selection and training in all departments i.e. production, packaging, labeling, etc.
- Specific procedures can be applied to attain the best quality.
- In case of building we ensure that there occurs no contamination in anyway, there is separate tablet and liquid sections, even there is complete. separation in tablet machines, all the machines have separate cabinet.
- The equipments are constructed and fitted in such a way that it is easy to replace, easy to wash easy to operate and easy to empty.
- The surfaces of equipments are non-reactive, non-absorptive and non-additive
- They are constructed in a proper size and in proper way, with the provision to process a complete batch at once.
- The equipments and building used in storage, processing, checking and packaging are of a suitable design, size, construction and location.
CONTROL OF RECORDS:
- We maintain records such as master formula record and batch production record.
- The master formula record is prepared for each product.
- It is signed by a competent and responsible person.
- It is then checked by another competent person and is countersigned.
- The master formula varies from production to production and from batch to batch.
It includes the following information:
- Name of the product, dosage form and strength.
- Complete list of ingredients including excipients.
- Quality by weight or volume of each and every ingredient.
- Standards or specifications of each ingredient.
- Any calculated excess of an ingredient.
- Theoretical yield and termination of process.
- Manufacturing and control instructions, specifications and precautions.
- Complete description of closures, containers, labeling, packaging and other finished material, etc
- Both Quality Control and Production Departments are responsible for the production procedure control.
- In the production procedure control, some tests are done during the process, which is called “In Process Quality Control (IPQC)”
- This master formula is taken into the store and all the materials for the batch are weighed and delivered to Production Department.
- All ingredients are rechecked and tested in laboratory.
- A complete list of ingredients along with their quantities is delivered to the Production Department. It is called Master Formula of that batch.
- It contains all the information of that batch i.e. procedures and equipments to be used and precautions to be taken, etc.
BATCH PRODUCTION RECORD:
- Batch production record is prepared, maintained and controlled for each batch of a product.
- It is retained for about 5-years after product and distribution.
Batch production record have the following information in addition to master formula record:
- Batch number.
- Code number.
- Manufacturing date.
- Expiry date, etc.
- When the product come in packaging section, it should be packed in recommended containers and there should not be any mistake in case of labeling and writing of batch number, etc
- The packaging control is usually completed before manufacturing of product.
- We ensure proper and effective distribution of the products as per demand.
- The responsibilities of Quality Control Department are not finished even after the distribution of finished dosage form in the market.
Evaluating methods and processes of production:
- It is a corrective measure to maintain the quality.
- Locating quality deviations: It is necessary to analyse the trend and extent of quality deviations in a manufacturing process, which should be explained by statistical techniques. Establishment of quality standard: Main motive of QC is the economical production of a high quality product at the quality level the customer wants
OBJECTIVES OF QUALITY CONTROL
- Improvement in quality Aims at creating quality consciousness at all levels in our organisation.
- We aim at manufacturing standard quality products and ensure to avoid the production of inferior quality goods.
- This guides us and accelerates the sale of the goods since we are suppliers of only the quality goods.
ADVANTAGES OF QUALITY CONTROL
- Improvement of the quality of production and reduction in the production cost.
- Uniformity in the production and supply of standard quality goods to consumers.
- Offering full return of the price paid by the consumers and giving convenience and satisfaction to consumers .
- Reduction in spoiled production and rejection from consumers and dealers.
- Promotion of exports due to superior and standard quality production.
- Reduction in periodic inspection cost.
- Making products popular in market.
- We strive so as to achieve new levels of glorious performance.
- It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use.
- It is that part of GMP aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use.
- All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality is assured.
Words of NVRON:
- By just controlling Manufacturing operation or person…..we can never assure customers about the quality which we claimed.
- If we miss to take care, then we cannot give the assurance of the product. And if customer is not happy by my product, we will lose him.
- We have the mindset to look and have control over everything related to the making of product like Equipment and Instrument Quality
- Operational Quality
- Ancillary Material Quality
- Persons engaged in whole operation (Store, QC, QA, Production, Logistics, IT, etc.)
- Raw Materials Quality and overall finished product quality.
- Quality Assurance is a dynamic process. It’s a journey towards the destination.
- All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.
- Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials.
- Product and control operations are clearly specified in a written form and GMP requirements are adopted.
- Products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release ofour products.
- The finished products is correctly processed and checked according to the defined procedures.
- There is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system.
- Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed and subsequently handled so that quality is maintained throughout their shelf-life.
REGISTRATION OF DOCUMENTS
- Documentation of the process from staring material to the end user and its storage is done.
- Evaluation and Analysis of the Deviations, Out of Specification results and Change Controls during the Manufacturing are documented.
- Regular evaluations of the quality of our pharmaceutical products have been conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement and they are documented.
TOTAL QUALITY MANAGEMENT
- "A process designed to focus on customer expectations, preventing problems, building commitment to quality in the workforce and promoting open decision-making.“
- It is a comprehensive concept.
- Not restricted to only goods and services.
- High quality standards has been maintained in other aspects of management such as production cost, marketing, sales promotion, etc.
- To achieve this quality/efficiency-we do develop consciousness/awareness among employees working in all departments of the enterprise.
- Co-operation/involvement is the golden key that we do maintain in all aspects of business management.
- In brief, we believe that quality management is not the responsibility of management alone, it requires the participation/involvement of both parties (management and employees) for the achievement of quality and other benefits.
We aim at:
- Consumer satisfaction and pleasure.
- We stress on consumer expectations, total commitment to quality and participative management.
- Facing market competition effectively, to create goodwill and to have support of consumers.
- Motivating employees and also for giving them better facilities, training and participation in decision-making.
- Facilitating industrial growth, economic progress and prosperity to the nation Collective efforts are being made for improving quality of goods and services to give more satisfaction to consumers.
- Quality improvement is also useful for facing market competition and for creating market reputation.
- TQM involves steps for improving quality and productivity.
- There is total commitment to quality on the part of entire Organization.
- We do continuous process/activity as there is ample scope for using new methods and techniques for improvement in the quality standards and performance.
- TQM is a never ending quest for achieving new levels of performance.
- We strive so as to achieve new levels of glorious performance.