Good Manufactured Practices, or GMP, is a system made up of steps, instructions, and paperwork that guarantees that manufactured commodities like food, cosmetics, and pharmaceuticals are regularly produced and monitored following predetermined quality standards. GMP implementation may reduce losses and waste while preventing recalls, seizures, penalties, and prison time. Overall, it guards against harmful food safety incidents for the business and the customer. Every step of the manufacturing process is examined and covered by GMPs to prevent hazards that might have disastrous effects on the goods, such as cross-contamination, adulteration, and misbranding. This is one of the reasons why one should look for a WHO GMP Certified manufacturer In India only. Here is what one should know about it.
What is it about?
GMP is the fundamental standard that the US Food and Drug Administration (FDA) has established following the Federal Food, Drug, and Cosmetic Act to ensure that manufacturers are taking proactive measures to ensure the safety and efficacy of their goods. To guarantee consistent product quality and safety, the manufacturing sector must strictly enforce GMP in the workplace. The following are some areas that GMP guidelines and regulations might affect in terms of product quality and safety:
- Sanitation and hygiene in quality management
- Structure and amenities
- Equipment
- Personnel Resources
- Qualification and attestation
- Complaints
- Record-keeping and documentation
- Examinations and quality checks
Regulations And Standards
Producers are required to follow GMP laws to control the production, verification, and validation of produced goods and guarantee their efficacy and safety for market distribution. Current Good Manufacturing Practices (CGMP), which encompass a wider variety of sectors, including cosmetics, food, medical devices, and prescription pharmaceuticals, are how the FDA enforces GMP. The standard of produced goods is strictly monitored since it might harm consumers and even environmental health.
GMP standards are created to increase the safety of manufactured items, particularly pharmaceutical products, and to guarantee that customers receive the best available products. Following GMP guidelines improves manufacturing organizations’ image while lowering the number of batches, recalls, and consumer complaints.
Basic Guidelines
A thriving manufacturing process may be implemented with the support of GMP guidelines, a set of principles that guarantee quality is ingrained throughout the business and the procedures involved. GMP regulations are typically forgiving, and each nation has legislation that must adhere to its principles and regulations.
Quality management aims to guarantee that manufactured goods are suitable for their intended use, conform to specifications, and do not endanger customers via insufficient safety, quality, or effectiveness controls. Quality assurance, excellent manufacturing processes, quality control, and risk management should be fully and accurately executed to meet this quality aim.
In every step of the production process, hygiene and sanitation are essential. It includes everything potentially contaminating a product, including workers, the environment, tools, containers, and manufacturing supplies. The property’s location should be suitable for its activities and free from hazards that might cause materials and goods to become contaminated. Additionally, the location should be simple to keep clean and maintain and should be built to reduce operational mistakes. Verifying crucial production procedures is necessary to guarantee that high product quality standards are consistently met.
GMP, or good manufacturing practices, guarantees that Sricure herbs manufacture items in a way that satisfies quality requirements while also controlling quantity. GMP takes into account several variables, including cleanliness and environmental conditions. Any faults or abnormalities can be found sooner through this method than they would be once the finished product has been evaluated or is on the market.
| Medicine | Origin |
| Premarin | Refers to “pregnant mares’ urine”, the source from which the conjugated estrogens are taken. Premarin is used to treat postmenopausal women suffering from hot flashes. |
| Warfarin | Takes its name from the acronym WARF – Wisconsin Alumni Research Foundation, and ‘-arin’, coming from the link between warfarin and coumarin. |
| Morphine | Takes its name from the Greek god of dreams, Morpheus. |
| Montelukast | Montelukast, a drug used to treat COPD, takes its name from Montreal, the site of its discovery. |
| Glucophage | The medicine whose active ingredient is metformin, a drug used to treat type 2 diabetes. The name Glucophage derives from the Greek to mean “glucose eater”. |
| Halcion | Triazolam is the active ingredient of Halcion; a drug used to treat severe insomnia. The name “Halcion” comes from the Greek concept of “calmness” – now most associated with calmness at sea. |
| Lasix | Refers to “last 6 hours”. Lasix is a medicine used to treat fluid build-up (its active ingredient is the drug, furosemide), with diuresis being complete within 6 hours. |
| Nystatin | An antifungal medicine whose name derives from New York State Department; the developers of the drug having worked in that department during its discovery. |
| Rapamune | Whose active ingredient is sirolimus. The drug itself was first isolated from samples taken from Rapa Nui, the native name of what is called Easter Island. |
| Valium | Takes its name from the Latin word, “vale” – referring to “farewell / goodnight”. The active ingredient of Valium, diazepam, is used to treat a wide variety of conditions such as anxiety, seizures, and muscle spasms. |
| Emend | Referring to “ending emesis”, or vomiting. The active ingredient of Emend is aprepitant, an NK1 receptor antagonist. |
| Ursodiol | The active ingredient of which is ursodeoxycholic acid, a drug used to reduce gallstone formation. Ursodiol takes its name from “urso”, or “bear”, as bear bile is a source of the drug. |
| Actigall | Also contains the active ingredient ursodeoxycholic acid, though its name refers to “acting on the gallbladder”. |
| Prevacid | “Preventing acid formation”. That’s because the active ingredient of Prevacid is lansoprazole, a proton-pump inhibitor. |
| Ambien | Takes its name from the Spanish to mean “Good morning!” (AM – morning and ‘bien’ – good). The active ingredient of Ambien is zolpidem. |
| Fosamax | The active ingredient of which is alendronic acid. The name Fosamax comes from the Latin “os” to mean “bone” and “max”, to maximize its effect. |
| Macrobid | Takes its name from “Macro-“, referring to Macrodantin, and “-bid”, referring to the Latin for twice daily. The active ingredient of Macrodantin is the antibacterial drug, nitrofurantoin. |
| Xarelto | The active ingredient of which is the anticoagulant medicine, rivaroxaban. Xarelto takes its name from factor ‘Xa’, the factor that rivaroxaban inhibits to impart its anticoagulant properties. |
| Tylenol | Takes its name from the chemical structure of acetaminophen (paracetamol) – N-aceTYL-para-aminoPHENOL. |
| Lunesta | Takes its name from “Luna”, the Latin word for the Moon. The active ingredient of Lunesta is eszopiclone, a drug used to treat insomnia. |
| Flomax | A drug used in the treatment of benign prostatic hypertrophy, a condition that causes limited urine output. The active ingredient of Flomax, tamsulosin, is an alpha-receptor blocker that promotes urine flow. |
