Service International

Green Park, Delhi

Good Manufacturing Practice - GMP is a term that is recognized worldwide for the control and management of manufacturing, testing and overall quality control of food and pharmaceutical products. GMPs have been used by the pharmaceutical and healthcare manufacturing industries for over 50 years as a means of assuring that products have the identity, strength, purity and quality that they purport to contain. GMPs are in effect in over 100 countries, and GMP compliance is a pre-requisite to exporting pharmaceuticals between countries. GMP takes quality assurance approach, which ensures that products are consistently produced and controlled according to the quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. It covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. It is believed that GMP is a good business tool, which helps to refine both compliance and performance of the company. GMP requirements are largely common-sense practices, which help companies better themselves as they move toward a quality approach using continuous improvement. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.

GMP Certification

Service International, a leading GMP Consultancy in India, is having vast industrial experience in the implementation of GMP for all types of Pharmaceutical industries. 

We are a well established name for giving CE Mark Adviser Services. We offer safe and secure, Ce Marking Certification with very reasonable rates. Ours is a well established CE Mark Certification in India which is worth its value and adhering with various European safety standards, depending upon the end- products.

What is CE Marking (CE Mark)?The letters "CE" are the abbreviation of French phrase "Conformit Europene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents. "CE Mark" is also in use, but it is NOT the official term. CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives. Product Directives contains the "essential requirements" and/or "performance levels" and "Harmonized Standards" to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc).

• CEN stands for European Committee for Standardization
• Cenelec stands for European Committee for Electrotechnical Standardization
• CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country
• CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries)
• CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities

Along with more directives' becoming effective, more and more products are required to bear the CE Marking for gaining access to the EFTA & European Union market. However, many non-EU exporters are still unaware of or unsure about this fact and its impact on their business. What products need to bear CE Marking?CE Marking is most probably required if you export to the 25 European Union (EU) and 3 European Free Trade Association (EFTA) member states the following 22 groups of products - Appliances Burning Gaseous Fuels (AppliGas):The "appliances burning gaseous fuels" used for cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding 105 gC. Forced draught burners and heating bodies to be equipped with such burners will also be considered as appliances. The "gaseous fuel" means any fuel which is in a gaseous state at a temperature of 15 gC under a pressure of 1 bar. Cableway Installations to Carry Persons : The "cableway installations designed to carry persons" shall mean installations made up of several components, designed, manufactured, assembled and put into service with the object of carrying persons. These on-site installations are used for the carriage of persons in vehicles or by towing devices, whereby the suspension and/or traction is provided by cables positioned along the line of travel Low Voltage Electrical Equipment :The "Electrical Equipment" means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current (A.C.) and between 75 and 1500 V for direct current (D.C.). Therefore, it is called often "Low Voltage Electrical Equipment" which includes the vast majority of electrical equipment in everyday use. Construction Products :The "construction product" means any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works Equipment and Protective Systems for Used in Potentially Explosive Atmospheres(Atex)

• Equipment means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy for the processing of material and which are capable of causing an explosion through their own potential sources of ignition
• Protective systems means design units which are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems
• Components means any item essential to the safe functioning of equipment and protective systems but with no autonomous function. Explosive atmospheres Mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture

Explosives for Civil Uses :The "Explosives" here shall mean the materials and articles considered to be such in the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations Hot Water Boilers :The "hot-water boilers" here means a boiler fired by liquid or gaseous fuels with a rated output of between 4 kW and 400 kW (including 4 kW and 400 kW). Household Refrigerators & Freezers : Lift : The "lift" here means an appliance serving specific levels, having a car moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and intended for the transport of :

• Persons
• Persons and Goods
• Goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside

Machinery :The "Machinery" Means :

• An assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material
• An assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole
• interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool

Marine Equipment :The "Marine Equipment" here means items listed in Directive 96/98/ec Annexes A.1 and A.2 which must be placed on board a ship for use in order to comply with international instruments or are voluntarily placed on board for use, and for which the approval of the flag State administration is required according to international instruments Medical Devices :A "Medical Device" is defined in Directive (93/42/EEC) as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :

• Diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap
• Investigation, replacement or modification of the anatomy or of a physiological process
• Control of Conception

Active Implantable Medical Devices :The "active medical device" means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity. The "active implantable medical device" means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure. In Vitro Diagnostic Medical Devices :The "in vitro diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information. Non-automatic Weighing Instruments :

• A "Weighing Instrument" is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics
• A "non-automatic weighing instrument" is defined as a weighing instrument requiring the intervention of an operator during weighing

Radio Equipment & Telecommunications Terminal Equipment (R&TTE)

• A "radio equipment" means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radiocommunication
• A "telecommunications terminal equipment" means a product enabling communication or a relevant component thereof which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunications networks (that is to say, telecommunications networks used wholly or partly for the provision of publicly available telecommunications services)

Personal Protective Equipment(PPE) :The "personal protective equipment" means any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards. Simple Pressure Vessels :The "simple pressure vessel" means any welded vessel subjected to an internal gauge pressure greater than 0, 5 bar which is intended to contain air or nitrogen and which is not intended to be fired. Pressure Equipment :The "Pressure Equipment" means vessels, piping, safety accessories and pressure accessories. Where applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc. 'Vessel` means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment. A vessel may be composed of more than one chamber. 'Piping` means piping components intended for the transport of fluids, when connected together for integration into a pressure system. Piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate. Heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping. 'Safety accessories` means devices designed to protect pressure equipment against the allowable limits being exceeded. Such devices include :

• Devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS)
• Limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and 'safety related measurement control and regulation (SRMCR)devices

'Pressure accessories` means devices with an operational function and having pressure-bearing housings. 'Assemblies` means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole Recreational Craft :The "Recreational craft" means any boat of any type, regardless of the means of propulsion, from 2, 5 to 24 m hull length, measured according to the appropriate harmonized standards intended for sports and leisure purposes. Toys :A "toy" shall mean any product or material designed or clearly intended for use in play by children of less than 14 years of age. Trans-European Conventional Rail System :The "Trans-European Conventional Rail system" means the structure composed of lines and fixed installations, of the trans-European transport network, built or upgraded for conventional rail transport and combined rail transport, plus the rolling stock designed to travel on that infrastructure.

Among the broad array of services, there exists Service of ISO Consultancy. We provide ISO Certification Services to add value to organizations by offering advice on appropriate areas of operation. The ISO 9001: 2000 consultancy Services Provided by us are available at reasonable rates. We invite you to come and become a part of our family and avail these excellent services.

n

Estimated Time Frame Development Phase Time Schedule

n

n
• Phase I (8-10 Weeks)
n
• Phase II (4-6 Weeks)
n
• Phase III (8-10 Weeks)
n
• Phase IV Depends on the Certification Body (Generally 3-4 Weeks)
n

n

(N.B.The fees shall be quoted, after the receipt of details indicted in Client Information Proforma). The Consultant would also ensure that AUDIT is completed satisfactorily well and document is accepted in Pre/Post AUDIT The Quality Manual and Processes are made in line with the International Standard. The other parameters are as per Modules indicated and we shall adhere to the time schedule. The development of a quality management system of your organization would involve the following phases: Phase IExposure on ISO 9000 and Development of Quality System Procedures and Associated Documents

n

n
n
• Awareness programme on ISO 9000-2000 series of standards
n
• Review of Organization's Quality Policy
n--Review of Business Goals and identification of Objectives
n

n

 

n

n
--Establishment of measurable objectives relating to Key Process areas
n

n

 

n

n
--Review of the existing system in operation
n

n

 

n

n
• Outline of quality management system documentation
n
• Development of a numbering system for documentation of the quality management system
n
• Identification of quality management system procedures required
n
• Development and writing of quality system procedures
n
• Designing of work instructions
n
• Identification and development of forms/formats
n
• Identification of quality system records
n

n

On completion of this phase the managers and supervisory personnel will have sufficient knowledge to appreciate how their particular operations fit into the requirements of ISO 9001 and the quality system procedures and associated documentation will be ready for implementation Phase IIDevelopment of Quality Manual

n

n
• Writing of the Quality Manual
n
• Finalization of the Company's Quality Policy
n

n

On completion of this phase the Quality Manual will be ready. Phase IIIInstallation and Evaluation of the Documented System

n

n
• Training of internal quality auditors
n
• Conducting a trial audit of the system
n

n

It may be noted that staff training schedule will be conducted here itself as per detailed discussion with the management. On completion of this phase the system will be ready for application to the certification agency. Phase IVCertification Audit

n

n
• Final audit by third party certification body
n
• Assisting in resolution of non conformities raised by authors of certification body
n
• Charting the follow up action on the report of certification body
n

n

Main Advantages of ISO Certifications Symptoms of Poor Quality

n

n
• Complaints : you spend a lot of time dealing with (or avoiding) irate customers.
n
• Time : you never have enough time for the necessary and important work.
n
• Hassle : There are always fires to put out.
n
• Overload : you always have too much to do.
n
• Under-Load : Others dump their work to you.
n
• Confusion : No one seems to know what is going on.
n
• Neglect : No one wants to hear your views or problems.
n

n

On completion of this phase your organization becomes certified to ISO-2000. What is Quality

n

n
• Quality is meeting customer requirements
n
• Quality is a concept that everyone agrees is important, but no one acts to achieve it in any tangible way
n

n

Before Implementation of QMS

n

n
• All businesses have an established way or system of doing businesses, likelihood is that system is quite effective, but informal and probably not documented.
n
• Measurement of Quality in each process and overall for organization do not exists
n
• Problems as they are faced are handled no conscious efforts are made to prevent the recurrence
n
• Useful data wrt achievements and problems faced is not collected
n
• Knowledge is not preserved
n
• Responsibilities and authorities are unclear there are misunderstandings at times
n
• Employees are not trained to be quality conscious, there are rejections / customer complaints due to poorly defined processes and negligence
n
• Whenever people change, training new person takes time
n

n

After ISO 9001 Implementation Internal Improvements

n

n
• Confidence to management that the intended quality is being achieved and maintained
n
• Clarity, uniformity in the working
n
• Processes are controlled, such that non-conformances are prevented (not detected)
n
• Planned continuous quality improvement efforts
n
• Reduce production costs because money is no longer spent on waste and rework. The savings can be reinvested in new technology and in reducing the cost to the customer
n

n

Recognition

n

n
• Some customers in are looking for the confidence that can be given by a business having a quality system
n
• It establishes company's credibility among customers
n

n

What is Process Improvement?Business is about people working with other people. customers, managers, staff, and suppliers. A quality process makes us look again at the way all these people work together with the challenge that it can and must be done better than before.

n

n
• Can we create more value and less waste in those processes
n
• Can they be made faster, more robust, practical, and more flexible?
n

n

Symptoms of Good Quality

n

n
• High customer satisfaction
n
• Repeat orders  reduced marketing costs
n
• First time right every time, - No reworks or wastages.
n
• Increased sales and profits.
n
• Low attrition rate of employees. Good employees stay.
n

n

Client Information ProformaJust complete the following profile Form and well send you our Proposal for consultancy training :

n

n
• Name of Company
n
• Office Address
n
• Works Address(S)
n
• Contact Person Name & Designation
n
• Product Manufactured
n
• No. of Employees
n
• Turnover
n
• Details of any other Quality System already existing
n
• Target date to achieve certification
n
• Any other relevant information
n

Our ISI Consultantancy Services have been designed to process all needs of the clients electronically. Our ISI Consultancy services are meant to fulfill all of your needs with a full assurance of complete satisfaction from our side. Our unique ISI Consulting Service will really work well for you. That's our promise! Road Map for Granting Licence for BIS Product Certification Issue of Application Form from Bureau of Indian Standards (BIS) Corresponding relevant ISI standards to be procured from the department Filling of application form in all respects, as per format Finalization of testing equipments/instruments, as per ISI standards Details of test procedures to be adopted Details of the process of manufacture Submission of the application form , duly filled in along with testing equipments/instruments, detail of the test procedure, process of manufacture, other enclosures and required fee of the department Selection of lab Incharge ( having required qualification & experience) in order to carry out tests , as per required standard Fixing of inspection date to be conducted by technical official of BIS Sealing of test samples of the manufacturing unit to be forwarded for conducting various tests, in accordance with the ISI standads from outside lab , recognised by BIS In case, the test samples are found O.K., the client is accordingly informed in writing, along with the test results Scheme of testing is finalized by BIS officials, in case the BIS certification is being awarded for the first time or the same is available To deposit licence fee for issue of CML No. by BIS BIS certificate is issued by the department, with one year validity Re-issue of the certificate, after expiry of one year, after due inspection by BIS and deposition of renewal fee for the period.