why good manufacturing practice is a must in chemical industry ?

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 : chintan@tatvachintan.com

shekhar@tatvachintan.com

sales@tatvachintan.com