Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.
GMP is designed to minimize the risk of error involved in any pharmaceutical production. Once the product is made the error cannot be removed.
The main risk of endangering quality are:
- At the stage of packaging risk of contamination of products, causing damage to health or even causing death.
- At the stage of labelling incorrect levels on containers, would mean that the patients will use the wrong medicine.
- At the stage of formulating insufficient or excess of active ingredients, resulting in ineffective results or adverse effects.
GMP covers all aspects of production; from materials, premises and equipment to the training and personal hygiene of the staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. Every time a product is made systems must be adapted to provide documented proof that correct procedures have been consistently followed at each step in the manufacturing process as per GMP.
Good quality ingredients must be incorporated during the manufacturing processes; it is difficult to test the product afterwards.
Without GMP, it is impossible to ensure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.
WHO has established detailed guidelines for good manufacturing practice. Many countries have laid down their own parameters for GMP based on WHO’s GMP. Others have synchronized their parameters; for example in the association of Southeast Asian nations, in the European Union and through the pharmaceutical inspection convention.
Implementation of GMP is an investment in good quality medicines production. This will improve the health of the individual patient and the community. It also benefits the pharmaceutical industry and health professionals.
Poor quality medicines
- A poor quality medicine may contain toxic substances that have not been tested prior to formulation.
- A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.
- Making poor quality products does not save money in the long run, it is more expensive finding mistakes after they have been made GMP is designed to ensure that mistakes do not occur.
- Manufacturing and distributing poor quality medicines leads to loss of credibility of both public, the healers and the manufacturer.
GMP helps boost pharmaceutical export opportunities
- Mostmost of the countries only allow import and sale of medicines that have been manufactured and internationally recognized GMP.
- Governments seeking to promote their countries export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.
GMP requirements: at a glance
- Should account for the herbs and other ingredients being processed.
- Should tally quantities between different processes.
- Semi- finished products must be labelled.
- Should be able to track back the source of raw materials and packaging materials.
- Surrounding area must be kept hygienic.
- Units should be far from a chemical or any hazardous substances processing zone.
- Introduction boards must be displayed at all points.
Internal environment of factory
- Floor must be cleaned regularly.
- Exhaust fans must be used.
- Machinery must be cleaned as well as overhauled regularly.
- Daylight bulbs must be in used in shifts.
- All Windows must have nets.
Material handling stories line clearance
- All all items must be stored on palace pallets
- All items must have levels with identification and relative information
- Harsh must not get mixed up
- Insurance of all materials must be on first come first served basis
- All items must be given status levels
- All previous raw materials must be removed.
- All paperwork entries must be duly completed.
- All machinery must be cleaned prior to the commencement of next job.
- All semi- finished products must be stored separately and carefully labelled.
- All previous packing items must be removed.
- Justification must be given for any previous item not being removed.
- Must be followed for every single changeover.
Quality assurance system
- Records must be maintained for any defect observed.
- Analysis of trends in defects must be conducted at regular intervals.
- Samples of incoming and outgoing goods must be maintained.
- Formats must provide for checks on all specifications.
- Inspection must be at periodic intervals.
- Emphasis must be on preventive measures.
- Final inspection reports must accompany every consignment.
- Inspection instructions must be displayed.
- All defects must be codified.
- Standards specifications must be displayed.
- Samples of in-process defects should be maintained with proper identification.
- Master list of all analysis must be made.
- Benchmarking must be used for reviewing performance.
- Individuals must be there own assessments.
- Graphical representation for easy understanding should be maintained.
- Action taken must be reviewed.
Health, safety and sanitation
- Should have no values of noise pollution.
- Should have proper ventilation.
- Health checkup should be mandatory.
- Protective glasses must be provided.
- Training must be provided.
- Alarms must be regularly checked.
- Fire drills must be conducted.
- First aid box must be handy.
- Washing facilities must be provided outside the production area.
- Washrooms must be cleaned regularl, dustbin must be cleaned regularly.
- Location of sanitary facilities should be away from manufacturing area.
Hygiene/ cleanlines/clean clothing
- Personal belongings should be disallowed in the plant.
- Separate area for lunch and tea.
- Dirty uniform should be disallowed.
- Sterile gloves to be used while handling materials.
- Lockers must be available.
Customer complaints /rework /rejects recording
- Should record all complaints.
- Should investigate the root cause.
- Should take corrective and preventive action.
Packing, delivery, material handling, storage
- Filled boxes should be sealed with BOPP tape.
- Proper labelling on the fixed boxes.
- Avoid use of damaged cartoons.
- Identification labels on semi- finished goods and raw materials.
- Closed area for final packing.
Corrective and preventive measures
- A list should be made of all preventive measures that are possible for the defects that occur.
- Complaints stated should be highlighted with the corrective and preventive action.
- Corrective and preventive measures undertaken during the month should be recorded.
- Review of all corrective and preventive measures should be made on monthly basis.
Schedule-T (GMP for ISM drugs)
Schedule-T was recforced on 23rd June 2000 for manufacturing units of Indian System of Medicine. The manufacturing units registered prior to this rule were given to 2 years time to comply with. Teaching institutions and registered qualified Vaidyas, Siddhas and Hakeems who prepare medicines on their own to dispense to their patients and not selling such drug in the market, are exempted from the purview of schedule-T. There is also provision of insurance of GMP certificate (form 26- E-1) after proper inspection of unit. This GMP certificate has validity for 2 years from the date of insurance.
Components of Schedule-T
GMP schedule for ISM Manufacturing Unit is quite elaborate and broadly covers each and every component of manufacturing process. Different components of GMP are given below in order to appear in schedule-T.
General requirements; such as location and surroundings, factory premises, buildings,water supply, containers, cleaning, disposal of waste, stores, raw materials, packaging materials, finished goods stores, working space, health, clothing, sanitation and hygiene of workers, medical services, equipments, bath and manufacturing record, distribution record, record of market complaints, quality control.
Requirement of sterile product;such as manufacturing areas and precautions against contamination and mix.
- List list of machinery, equipment and minimummanufacturing premises required for the manufacture of various categories of Ayurvedic and Siddha system of medicines.
- List of machinery, equipment and minimum manufacturing premises required for the manufacturing of various categories of Unani System of Medicine.
All the component of GMP provisions under schedule-T are grouped under different headings, viz. infrastructural requirements, working space, storage area, machinery and equipments, health and hygiene, documentation and quality control for explanation and elaboration on the subject matter. These are elaborated in force going text with regulator and objective subjective approach.