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 Medicines for
 Anti Diarrhoeal
Antimicrobial
Antidiabetic
Antacid/Anti peptic ulcerant
Laxative
Ophthalmological
Stomatological
Anitiinflammatory
Herbal
Others
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At the outset let us look at the CEOs perception on process improvement. The CEO of Wallmat while narrating the success story of the company said that "Process, Quality and Reliability are the important hallmarks of success".
With this let us look at the anatomy of GMP sequentially.
What is GMP ?
GMP is an abbreviated word which stands for good manufacturing practice. Simply speaking it speaks about standardisation based on uniformity, seguence and laid down steps (systems).
In any manufacturing activity the cycle is like a linear programming comprising input, process and output. Manufacturing is with a view to generate utility and utility generation is again with a view to satisfy wants/needs. Naturally manufacturing has to be in conformity with the expectation of the consumer. One has to be again proactive in regard to the expectation of the consumer since the economy has been opened up.
Market is no longer captive. It is ever changing and fierce competition is high on the agenda. Organisations need to leverage therefrom for survival not only in the domestic market but alsoin the transnational market place according to Darwinan industrial concept of 'survival of the fittest'. Consequence is obvious i.e. constant betterment and better for to-morrow as propounded in 'Kaizen' and other quality improvement techniques. The situation earlier was not this. Quality was viewed more on the basis of fitness for use as compared to conformance to end user requirement and consequent to this, segmentation took place between quality control and quality assurance as reactive and proactive endeavours to ensure convergence. GMP indeed is essential only the face of such business turbulence and warranting circumstances. Idimotically the situation is like to keep something on tenterhook as uncertainity, unforseen contingency and ushering a new era are constantly knocking.
Good manufacturing practice starts from the point of input and as a result, the logistics, plant layout, maintenance, skilled human resources, process control, inspection, checking all happen to be vital elements for consideration. It has to start from the doorstep and should continue in an ongoing manner on a continuous basis.
If business is to survive/converge with real life situation, it has to expand and grow.  Since domestic market is having a limited capacity based on the syndrome of monopolistic competition, entry to international market for better share though presupposes the generation of business but calls for simultaneous compliance of pre- conditions. GMP is one such essential pre-condition for entry into international market and overseas countries. GMP accreditation will enable the company to establish itself at the overseas market place as entry to international market calls for standardisation, uniformity and propriety especially for pharmaceutical products/industry and health care segment as a response to endeavour for human development around the globe.
International market serves international community .The degree of responsibility naturally is very high. Again medicine is a substance which needs to be used; simultaneously use has to be with care. The medicines and pharmaceutical items those will be marketed at the overseas market must have GMP accreditation which is more from the angle of social responsibility than the passport to market. GMP accreditation at least ensures standardisation, sequencing and uniformity for all practical purposes.
GMP is a comprehensive exercise. It has to be tuned with corporate objectives and marketing objectives as derived from corporate objectives. GMP Philosophy has to be inculcated into the minds of the organisational human. resources so that they are alert, proactive and conscious about at least the ABCs of GMP.
The diagram in the enclosed sheet will enlighten the situation.
1) Value of Training in GMP :
Training is important everywhere and in case of good manufacturing practice, it has to be with comprehensive excellence since training will be a combination of s\\rim model, Mckarsie model and has to be ongoing and continuous.
2) Requirement of GMP :
Basically two requirements :-
a) Structural b) Functional Structural : Plant location, facilities, utilities, standardisation.
Resource Input : Corporate policy, budgetory allocation, monitoring.
Functional : Process improvement, skill development, process control,
built-in-checks ( common).
Resource Input : Attitudinal ramification and moulding of behaviour through interface and mentoring sessions.
3) Documentation:
Documentation system has to be developed since documentation is a must for system/propriety audit at the same time quality audit on the basis of periodicity. Preservation should be as per laid down procedure. C .D .ROM system can be developed for effective space utilisation and long range planning standpoint. Cassette may also be developed to manage problems arising from space constraint for consistency, congency and coherence.
4) House keeping, Cleaning and Sanitation:
Proper cleaning, house keeping and sanitory arrangements .need to be there as an essential pre-requisite of GMP accreditation. Apt convergence should there between governing legislation and WHO norms i.e. the Factories Act, 1948 (wherever applicable) and WHO norms.
5) Validation and Calibration
Has to be done with suggested frequency from the competent authority.
6) SOPs & Record keeRing .
Standard operating procedures must be developed/followed and the same should be as per the model guideline in vogue. Awareness has to be developed so far SOPs are concerned Lucid presentation needs to be undertaken followed by evaluative demonstrative sessions for reinforcement and retention. Record keeping will continue as usual.
7) In Process Control
Built-in-checks have always played vital role in every sphere of activity without control, the case is like human organism without brain and in absence of control the desired objectives can not be achieved. Accomplishment of objectives is the main aim of any organised activity and inbuilt/process control is a catalyst in the process to accentuate/accelerate the same as per standard based on uniformity, sequence
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