why good manufacturing practice is a must in chemical industry ?
TRANSCRIPT
Good Manufacturing Practices (GMP)in
Cetrimide Manufacturing
Introduction
• Good Manufacturing Practices are the basic control measures and
procedures that have to be carried out to produce a product which
meets specificcations and is safe to consume.
• Such regulations that are under the force of law necessitate
processors, manufacturers, and packagers of medical devices, drugs,
blood and some food take the proactive steps to make sure that
every product they make is pure, effeective and safe.
Why GMP?
• Provides a high level assurance that medicines are manufactured in
a way that ensures their safety, efficcacy and quality.
• Medicines are manufactured to comply with their marketing
authorization.
• Good Manufacturing Practices facilitate record keeping, sanitation,
personal qualificcation, cleanliness, equipment verificcation, process
validation and complaint handling.
Quality Assurance
• Thee GMP regulations call for a quality approach to the process of
manufacturing, allowing companies to eliminate or minimize cases
of errors, contamination and mix ups.
• In turn, this will protect the consumers from buying a product
which is ineffeective or even dangerous.
• Firms who fail to comply with the GMP regulations may lead to
extremely serious consequences such as ficnes, jail time, seizure and
recall.
Good Manufacturing Practices
• Personnel Hygiene
• Physical facilities
• Storage practices
• Record-keeping
• Sanitation
• Process Validation
• Equipment Verificcation
CGMP
• Stands for Current Good Manufacturing Pracices.
• Manufacturers need to employ systems and technologies that are
updated in order to adhere to the regulation.
• Equipment and systems used for preventing contamination, errors
and mix ups, which could have been top of the line two decades
ago, may already be less than sufficcient by the present standards of
today.
Documentation• Writteen and detailed procedures are important or every process
which could have an impact on the quality of the ficnal product.
• All procedure (Manufacturing, Hygiene, Safety, Packaging, Storage,
Services etc.) must be documented.
• Theere should be systems to ensure that there is documented proof
which can show that correct procedures are being followed
consistently at every step in the process.
Cetrimides• Cetrimides can disrupt the growth of any harmful fungi and
bacteria through interrupting their normal functions.
• Thee processed food products, like meat and bread, contain the
quaternary ammonium compounds of cetrimide that act as a
preservative.
• With the right phase transfer catalysts, the cetrimide helps in
keeping foods fresh much longer through the regulation of pH
balance or acidity.
Advantages of Cetrimides• Cetrimides is a very active ingredient in the specialty shampoos for
treating dandruffe, psoriasis and eczema.
• It is also being used in the industry of pharmaceutics to ficght the
soften and state paper products as well as bind detergents.
• Thee cetrimide is also an active ingredient found in the topical ficrst
aid creams.
• Thee antiseptic properties that cetrimide has helps in the prevention
of infection in the open wounds like scrapes and cuts and this is
soothing for chapped hands and diaper rash as well.
Who we are?• Tatva Chintan Pharma Chem Pvt. Ltd, a leading raw material
supplier for various pharmaceuticals companies in India and
abroad.
• We maufacture a wide variety of various chemical products like
specialty chemicals, quaternary phosphonium salts, methylating
agents, electrolyte chemicals, etc.
• Thee quality product supplied by us at such an affeordable price has
made us a big hit in the industry.
Tatva Chintan Pharma Chem Pvt. Ltd.
502/17, G.I.D.C Estate,Ankleshwar - 393002, INDIA.
Phone Number : +91-2646-253593,238991
Fax Number :+91-2646-238992
Email Address : [email protected]