A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S. a drug may be deemed adulterated if it passes all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing guidelines. Therefore, complying with GMP is a mandatory aspect in pharmaceutical manufacturing.
Although there are a number of them, all guidelines follow a few basic principles:
Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary. Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices) Operators are trained to carry out and document procedures. Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented. Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form. The distribution of the drugs minimizes any risk to their quality. A system is available for recalling any batch of drug from sale or supply. Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.
As with costs, billing practices are important. Usually the time required for the project is intensive at the start and end of the project. Billing should reflect the initiation fee, a monthly billing schedule, and incentive for completing the goal: ISO certification.
Certifications?
Is the consulting company staffed by lead assessors and GMP experts? In assuring that your objects are achieved within desired time frames, consultants should possess both these qualifications.
Number of successful certifications, references?
Determine the experience of the consulting company in implementing quality systems for ISO certification and how many companies they have been able to obtain certification for. A good idea is obtaining references from other companies to determine how the consultants interact with the management team, convey and provide information, and meet defined goals.
Defined goals?
Does the consulting company set up a defined goal in the project plan using a milestone chart for the company? These defined goals are for both the company and the consultant, and they should be signed and agreed upon by both parties. If there are delays, these should be explained and documented in the project plan.
Do they practice what they preach: Are they ISO certified?
The consulting firm you ultimately choose should be ISO certified. If a consulting company has been operating under the ISO standard or Certified Body, it means they have hands on experience in how the program works and an understanding of the real value of the standard. This is especially true when related to the quality of customer service. Also, if the consulting company is ISO certified, it will make qualifying them easier as part of your vendor qualification program.
Closing.
The road traveled from GMP compliance to ISO certification is not just a matter of adding additional documents, but involves a mind set and an understanding of how quality systems are the same and how they differ. The process of obtaining ISO certification for a company already in GMP compliance does not have to be a daunting task of mass proportions. It is unfortunate that there are two standards that have to be dealt with but, for the most part, the GMP and the ISO standards for quality have the same ideas and requirements. Successful completion should be achieved without much pain
A product can be consistently well made according to GMP standards. But that doesn't necessarily mean it has the potential to improve health.
Quality to us doesn't mean just meeting a minimum standard of ingredient identity and sanitation. Or simply verifying that the product in the bottle matches the strength and concentration of ingredients printed on the label.
Our products have to meet our higher standards.
We put our name on every bottle—along with the tagline, "Makers of Professional Quality Supplements." To us, assurance of that professional quality means:
Exceptional purity of ingredients—with testing to meet our own strict guidelines and exceed industry standards Certified verification of ingredients by third-party assays—and extra testing for particularly volatile ingredients Tablets/softgels that dissolve when they're supposed to—we test every batch of tablets to make sure they disintegrate as they should Taste & tolerance tests—because quality to us also means that people like the product (so they'll take it and get the results their health care provider expects) Clinical evaluations—to monitor clinical outcomes, make suggestions for improvements, and help doctors recommend for their patients
A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S. a drug may be deemed adulterated if it passes all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing guidelines. Therefore, complying with GMP is a mandatory aspect in pharmaceutical manufacturing.
ReplyDeleteAlthough there are a number of them, all guidelines follow a few basic principles:
Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
Operators are trained to carry out and document procedures.
Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the drugs minimizes any risk to their quality.
A system is available for recalling any batch of drug from sale or supply.
Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.
Billing practices?
ReplyDeleteAs with costs, billing practices are important. Usually the time required for the project is intensive at the start and end of the project. Billing should reflect the initiation fee, a monthly billing schedule, and incentive for completing the goal: ISO certification.
Certifications?
Is the consulting company staffed by lead assessors and GMP experts? In assuring that your objects are achieved within desired time frames, consultants should possess both these qualifications.
Number of successful certifications, references?
Determine the experience of the consulting company in implementing quality systems for ISO certification and how many companies they have been able to obtain certification for. A good idea is obtaining references from other companies to determine how the consultants interact with the management team, convey and provide information, and meet defined goals.
Defined goals?
Does the consulting company set up a defined goal in the project plan using a milestone chart for the company? These defined goals are for both the company and the consultant, and they should be signed and agreed upon by both parties. If there are delays, these should be explained and documented in the project plan.
Do they practice what they preach: Are they ISO certified?
The consulting firm you ultimately choose should be ISO certified. If a consulting company has been operating under the ISO standard or Certified Body, it means they have hands on experience in how the program works and an understanding of the real value of the standard. This is especially true when related to the quality of customer service. Also, if the consulting company is ISO certified, it will make qualifying them easier as part of your vendor qualification program.
Closing.
The road traveled from GMP compliance to ISO certification is not just a matter of adding additional documents, but involves a mind set and an understanding of how quality systems are the same and how they differ. The process of obtaining ISO certification for a company already in GMP compliance does not have to be a daunting task of mass proportions. It is unfortunate that there are two standards that have to be dealt with but, for the most part, the GMP and the ISO standards for quality have the same ideas and requirements. Successful completion should be achieved without much pain
A product can be consistently well made according to GMP standards. But that doesn't necessarily mean it has the potential to improve health.
ReplyDeleteQuality to us doesn't mean just meeting a minimum standard of ingredient identity and sanitation. Or simply verifying that the product in the bottle matches the strength and concentration of ingredients printed on the label.
Our products have to meet our higher standards.
We put our name on every bottle—along with the tagline, "Makers of Professional Quality Supplements." To us, assurance of that professional quality means:
Exceptional purity of ingredients—with testing to meet our own strict guidelines and exceed industry standards
Certified verification of ingredients by third-party assays—and extra testing for particularly volatile ingredients
Tablets/softgels that dissolve when they're supposed to—we test every batch of tablets to make sure they disintegrate as they should
Taste & tolerance tests—because quality to us also means that people like the product (so they'll take it and get the results their health care provider expects)
Clinical evaluations—to monitor clinical outcomes, make suggestions for improvements, and help doctors recommend for their patients
Get your company ISO 9001:2008 Certified in most cost effective fee.
ReplyDeleteFast Services & 100 % Guaranty of certification
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Generic Standards :
ISO 9001(Quality Management System)
ISO 14001 (Environmental Management System)
OHSAS 18001 (Occupational Health & Safety)
ISO 27001 (Information Security Management System)
ISO 28000 (Supply Chain Security Management)
ISO 10002 (Complaint Management)
Integrated Management System
Industry Standards:
Automotive – ISO/TS 16949
Food Safety - ISO 22000, HACCP, GMP, Who GMP Compliance.
Medical Devices – ISO 13485, CE Directives
Pharmaceutical – GMP Audit Solutions
Logistics & Transportation – C-TPAT
IT – ISO 20000
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