Good
manufacturing practice (GMP) is used during the production and testing phases
of a product's lifecycle to ensure delivery of a consistently quality product
to customers. While many industries publish their own set of best practices
that govern the development of their specific products and services, the food
and pharmaceutical industries are usually the ones in reference when discussing
GMP. Here are ten of the guiding principles of GMP.
| Photo source: http://www.e-cleansing.com/certificate |
#1 Document Processes and
Procedures Clearly
Companies that follow GMP must not only have clearly defined processes and procedures, but they also must have them documented in a style that is free from ambiguity. Before changes are made to these processes and procedures, the update is thoroughly examined to ensure that quality is not degraded. These companies also must publish the updated documents so that all stakeholders know the correct protocols.
#2 Follow the Script
The second principle that guides GMP is following the documented processes and procedures exactly. Most companies employ quality assurance personnel to monitor work practices and provide the needed oversight to guarantee that work is being done as prescribed in the process and procedural manuals.
#3 Document Work for
Traceability
Completed work gets documented as well for quality control purposes. Whether a work outcome is good or unsatisfactory, quality control analysts trace possible causes via well documented work logs.
#4 Apply Validation
Mechanism for Products and Systems
Many times a worker will proclaim that work is “done” and submit a product for testing. However, GMP requires that there be a way to validate that the systems used during production actually performed as stated. These same validation tools are used to verify product performance and safety specifications.
#5 Facilities Built For
Product Quality and Employee Safety
GMP recognizes that manufacturing and other facilities within a product's supply chain greatly affects product quality. Companies that follow GMP build product quality elements into the design of the facility before production takes place. The facilities incorporate employee safety elements into the design as well.
#6 Maintaining Facilities
Poorly maintained facilities and equipment sometime result in product contamination and nearly always a loss of quality.
#7 Identifying and Applying
Job Quality Standards
For some workers, job quality and competency is a matter of public health and safety. It is important for organisations that are mandated to follow GMP to define job competency standards, set measurable objectives for meeting those standards, and check to see whether workers demonstrated job competency.
#8 Protecting the Integrity
ofa Quality Product
After producing a quality product, it is still important to protect the product against contaminating elements. A manufacturing or storage facility must be designed to prevent contamination at the level appropriate for the product's use by the customer.
Photo
source: http://en.wikipedia.org/wiki/Shower_ge
|
#9 Continue Implementing
Quality Processes throughoutthe Supply Chain
Even though certain supply chain activities are outsourced, it is still the responsibility of the regulated organisation to guarantee that quality products are delivered to their customers. This is done by partnering with reputable third party supply chain vendors that are committed to following the common quality standards of the industry.
#10 Implement Rigorous
Feedback and Recall Systems
Flaws in product quality are not to be ignored no matter the source of the complaint. In fact, these companies should have extensive feedback mechanisms that encourage the public or third party auditors to report quality defects. When defects affect product safety, the organisation's recall systems are activated to prevent public safety incidences.
Conclusion
The need for GMP within the food and pharmaceutical industries is evident because their products and services potentially impact the health and well-being of the general public. The Food and Drug Administrations of most developed nations place strict regulations on companies operating within these industries to ensure that GMP is followed.
Jasmine
works in a beauty salon and is asked regularly about the safety of cosmetic
products. She recommends visiting <a href="http://www.tracservices.co.uk/">Trac
Services/a> where you can see what legislations are in place on the cosmetic
and pharmaceutical industry.
No comments:
Post a Comment