GMPSOP

AUGUST 23, 2022

Table of Contents Quality risk management principles are already effectively utilized in many areas of pharmaceuticals manufacturing business. Our scope includes systems and processes that support manufacture and distribution of active pharmaceutical ingredients and drug products. How to apply quality risk management in validation?

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

GMPSOP

MARCH 25, 2024

manufacturing, packaging, testing, storage and/or distribution of products) shall be validated to provide assurance that their system is capable of producing without error and that the results are robust and reproducible.” Hardware is generally divided into 2 categories: i. Who should do what during Computer System Validation 1.

Documentation 59

Documentation Packaging Communication Pharmaceutical Companies 59

Pharmaceutical Technology

DECEMBER 9, 2022

Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings. Pharmaceutical Technology Excellence Rankings – The Verdict.

Vaccines 52

Vaccines Biosimilars Compounding Packaging 52

pharmaphorum

JUNE 1, 2021

Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain. However, traceability and security measures focused on the packaging level may not be enough to protect patients. Silica microtaggants.

Online Pharmacies 52

Online Pharmacies Dosage Packaging Pharmaceutical Companies 52

GMPSOP

MARCH 17, 2023

In a packaging line, a printer was used to imprint manufacturing and expiry dates on a batch of empty cartons which will be used to fill tablet strips. Further to corrective action, the defective packaging (carton) lot was destroyed which was initially quarantined. A fresh lot of unprinted cartons was issued for printing.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

PharmaState Academy

FEBRUARY 29, 2024

Competitive Analysis: Evaluating the market share and brand presence of established pharmaceutical companies and generic drug manufacturers. Studying consumer perceptions and brand loyalty towards existing products in the therapeutic category.

Health and Personal Care Stores 52

Health and Personal Care Stores Hospitals Communication Customer Service 52

FADIC

OCTOBER 24, 2023

The application includes submitting clinical drug trial data and information about the manufacturing process. Drug manufacturers also have to submit details about how the drug works in the human body, guidelines for dosage, and information on safety and side effects.

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Coverage and Processing Labelling Dosage 52

Quality Matters

MAY 23, 2023

For example, his group analyzed antibiotics purchased online and the potential safety risks specific to that treatment category. The results are unsurprising – numerous drugs are available on the Internet and can be purchased easily. What can we do?

Online Pharmacies 52

Online Pharmacies Controlled Substances Packaging Communication 52

European Pharmaceutical Review

OCTOBER 2, 2023

Silvia Forroova, Director of partnerships & sustainability, Informa Markets, commented: “We are very excited to be back in Barcelona, one of Europe’s premier biotech and pharma manufacturing hubs. At the heart of pharma, we provide the vital connections that will underpin growth in pharma manufacturing in the next few years.

Packaging 92

Packaging 92

GMPSOP

NOVEMBER 6, 2022

Primary reference standards as indicated under definitions, are substances manufactured and tested to compliance by a certified source. These secondary reference standards are originally used for manufacturing products, received with manufacturer’s certificate of analysis and tested to conform to specifications by laboratory on arrival.

Labelling 52

Labelling Documentation Packaging Communication 52

European Pharmaceutical Review

SEPTEMBER 15, 2023

For its 20 th anniversary, more than 180 entries across 12 categories have been narrowed down to determine the finalists the upcoming CPHI Pharma Awards. To recognise the influx of innovation across the pharmaceutical industry, three new categories are included in this year’s awards. Are you coming to the CPHI Barcelona 2023?

Packaging 106

Packaging Drug Development 106

GMPSOP

JULY 31, 2023

We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. Category 3: Configurable Software Configurable software is customizable to some extent but does not require full software development.

Documentation 52

Documentation Dosage Labelling Data Entry 52

GMPSOP

FEBRUARY 25, 2023

Table of Contents Importance of sampling in pharmaceutical industry Pharmaceutical sampling procedures are carried out during and at each major processing step during the manufacturing to ensure the highest quality is attained. These are called primary packaging materials. bottles, blister strips, aluminium foils, tubes, pouches etc.).

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Express Pharma

JANUARY 12, 2024

The government of India has been constantly taking several measures to encourage investments in the sector and promote local manufacturing and consumption, keeping cure and prevention in perspective. The time for commencing manufacturing or production was extended to 31 March 2024 by the Finance Act, 2022.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies Health Insurance Companies 52

Viseven

SEPTEMBER 14, 2023

It also bears extra replacement expenses when drugs are discarded due to improper packaging. Procurement methods, at any health system level, typically comprise the following categories: restricted tender, open tender, direct procurement, competitive negotiation, and international and local shopping.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Dosage 52

FDA Law Blog: Biosimilars

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

Packaging 64

Packaging Drug Development Documentation 64

GMPSOP

MARCH 8, 2024

In the early 1990s, the Food and Drug Administration (FDA) inspected a major generic manufacturer in the US and identified concerns with failing test results. The manufacturer challenged the FDA’s view, ending in the US District Court. For example, incorrect mixing times and heterogeneity of blends.

Documentation 52

Documentation Dosage Pharmaceutical Manufacturing Packaging 52

GMPSOP

OCTOBER 26, 2022

The validation process involves identifying and documenting the specific requirements that are established to manufacture the product and then demonstrating that the product consistently meets those requirements. Your company involves in manufacturing of pharmaceutical products. This validation is relatively less comprehensive.

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

PharmaShots

MARCH 9, 2023

Other Affiliations: Angela is an active Board of Director member of the Pfizer Foundation (a charitable organization addressing global health challenges), European Federation of Pharmaceutical Industries and Associations (EFPIA), and UPS (the global leader in package delivery and supply chain logistics). and Banco Bilbao Vizcaya Argentaria S.A

Clinical Pharmacology 40

Clinical Pharmacology Immunity Immunization Pharmaceutical Companies 40

European Pharmaceutical Review

FEBRUARY 22, 2023

These] data give us confidence to move forward with multiple programmes in parallel…and to expand manufacturing scale-up,” shared Imran. “We The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. the enteric coating and the capsule dissolve.

Biosimilars 83

Biosimilars Diabetes Immunity Immunization 83

Proxsys Rx

APRIL 19, 2024

In spite of the drug manufacturer restrictions that have devastated many hospitals’ programs, every one of the 13 health systems we serve and support has enjoyed significant 340B-revenue increases. I know other states, including Louisiana , have moved to shut down manufacturer restrictions. It’s a mystery to us.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Drug Pricing Packaging 52

Proxsys Rx

JANUARY 12, 2024

In spite of the drug manufacturer restrictions that have devastated many hospitals’ programs, every one of the 13 health systems we serve and support has enjoyed significant 340B-revenue increases. I know other states, including Louisiana , have moved to shut down manufacturer restrictions. It’s a mystery to us.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Drug Pricing Packaging 52

Pharmaceutical Technology

OCTOBER 23, 2022

Arbitrary limits given as milligrams of exposure to residues per device were simply prescribed based on the physical contact time allowed for each category of device. It is therefore essential that EO sterilized articles are subjected to sufficient aeration to remove such residues prior to final packaging by manufacturers.

Packaging 40

Packaging 40

GMPSOP

MARCH 4, 2023

Quality management system is primarily involved in ensuring good manufacturing practice (cGMP), good laboratory practice (GLP), good documentation practice (GDP), good automated manufacturing practice (GAMP) etc. How severe would the impact be if the identified risk were to occur during the manufacturing process?

Documentation 52

Documentation Communication Method Validation Packaging 52

PharmaShots

JUNE 1, 2023

These new results reinforce our differentiating data package for PDC*lung01. PDC*line can also be easily manufactured, as the cell source is independent of patients, and the drug product is shortly available for the patients.

Immunity 40

Immunity Immunization Vaccines Health and Personal Care Stores 40

The Thyroid Pharmacist

JULY 29, 2022

Indoor sources include flame retardants, upholstery, flooring and manufactured wood products, cleaning agents, etc. In this study, 25 “fragranced” products including laundry detergents, fabric softeners, dryer sheets, air fresheners and the like (many were top sellers within their product category) were tested. Heavy Metals.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

RX Note

FEBRUARY 23, 2023

Drug-Food Interactions - Predominantly the effect of food on absorption Drugs and Pregnancy - Discussing FDA Pregnancy and Lactation Final Rule and Australian Categories for Prescribing Medicines in Pregnancy Drugs and Lactation - Discussing key references Dosing in Obese - One dose fits all? Figures - Elemental iron and calcium content?

HIV Treatment and Prevention Agents 75

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 75

Pharmaceutical Technology

FEBRUARY 23, 2023

The framework classifies compounds based on their permeability and solubility (buffer solubility) properties into four categories (BCS I, II, III, and IV), and this system has been used by the industry for many years to assess in-vivo performance. Quotient Sciences supported a standalone DCS classification and formulation development package.

Drug Development 98

Drug Development Compounding Dosage Packaging 98