National Association of Boards of Pharmacy

OCTOBER 23, 2024

The exemption applies to “any … eligible trading partners, which … have successfully completed or made documented efforts to complete data connections with their immediate trading partners.” Know where your current product transaction information is being stored and how to access it.

Packaging 49

Packaging Documentation Pharmacy Technician 49

GMPSOP

MARCH 30, 2024

Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch. Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Express Pharma

DECEMBER 11, 2023

Proper documentation and effective data management were underscored as essential elements in building and sustaining a culture of quality and compliance within the industry. Embracing innovation in pharma packaging is vital become future Shivaji Chakraborty, Asst.

Packaging 94

Packaging Communication Documentation 94

GMPSOP

MAY 26, 2023

Imagine your company is going to install new information management software in the laboratory to replace the old one. The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintain documentation. Additional documents included each month.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Imagine your company is going to install new information management software in the laboratory to replace the old one. The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintaining documentation. Additional documents included each month.

Documentation 52

Documentation Packaging Communication Customer Service 52

European Pharmaceutical Review

NOVEMBER 24, 2022

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

Packaging 111

Packaging Labelling Documentation Dosage 111

Pharmaceutical Technology

SEPTEMBER 5, 2022

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Quality in terms of number of defective items, packaging and labelling, quality management system certification, research, development, and innovation.

Documentation 52

Documentation Packaging Labelling Pharmaceutical Manufacturing 52

Pharmaceutical Technology

MAY 17, 2023

Marketing Packages Taking part in the Excellence Awards offer your company many benefits including being able to tell the market, new and prospective clients about your achievement. For full details on the benefits, the scale of our audience and the marketing packages on offer please download the RESEARCH GUIDE.

Packaging 52

Packaging Documentation 52

GMPSOP

MARCH 3, 2024

Cross contamination is dangerous in pharmaceutical industry as it can severely compromise patient safety if the content is not pure and the product package differs from what is written on the label. Additional documents included each month. What are the examples of cross contamination in pharmaceutical industry?

Health and Personal Care Stores 52

Health and Personal Care Stores Packaging Labelling Documentation 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.” Additional documents included each month. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

Documentation 59

Documentation Packaging Communication Pharmaceutical Companies 59

GMPSOP

NOVEMBER 15, 2024

Stability testing ensures that the manufactured products remain safe, pure, and effective throughout their shelf life if they are kept in specified packaging and under environmental conditions. Additional documents included each month. Stability protocols are required to create a testing regime. All written and updated by GMP experts.

Packaging 59

Packaging Dosage Documentation Labelling 59

Pharma in Brief

MARCH 18, 2021

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. Consultation on the draft guidance document is open until May 7, 2021. Any non-drug information must be derived from trusted, high-quality sources.

Labelling 40

Labelling Documentation Packaging 40

Quality Matters

NOVEMBER 5, 2024

API DMFs are documents containing information on APIs that are submitted to the U.S. Food and Drug Administration (FDA) by API manufacturers to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.

Pharmaceutical Manufacturing 75

Pharmaceutical Manufacturing Packaging Documentation 75

Express Pharma

MAY 24, 2024

Adding to that, the companies which are specialised in nutraceutical use a high-quality control as the main aspect of manufacturing, packaging, and distribution. The distribution of these roles includes the supervision of production processes and in-process inspections together with keeping complete documentations of manufacturing activities.

Labelling 98

Labelling Packaging Documentation Dosage 98

FDA Law Blog: Biosimilars

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

Documentation 75

Documentation Packaging Communication Labelling 75

Express Pharma

JUNE 2, 2023

As part of these efforts, the government has implemented regulations mandating API (active pharmaceutical ingredient) manufacturers and pharma brands to incorporate barcoding on product packaging. This regulatory step is aimed at preventing falsified medicines from entering the market.

Adverse Reactions 89

Adverse Reactions Packaging Documentation Dosage 89

Pharmaceutical Technology

MARCH 10, 2023

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing decision. Role of freeze-drying systems in the pharmaceutical industry The pharmaceutical freeze-drying market is highly governed by stringent standards and laws.

Documentation 59

Documentation Vaccines Pharmaceutical Manufacturing Packaging 59

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

Labelling 57

Labelling Packaging Documentation 57

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

GMPSOP

NOVEMBER 19, 2023

Additional documents included each month. If significant trends are identified, they should be documented, and changes should be made to avoid out-of-specification results. The number of batches manufactured, released and rejected should be documented. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. These standardised documents provide meticulously curated and scientifically approved information. 11 This requirement directly contradicts what is included in Article 63.

Packaging 98

Packaging Documentation Communication Pharmaceutical Companies 98

Pharmacy Joe

OCTOBER 25, 2023

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

Dosage 111

Dosage Inpatient Packaging Documentation 111

Syner-G

SEPTEMBER 28, 2023

There are common, though preventable, pitfalls that applicants may encounter, including incomplete or inadequate nonclinical data, which can be addressed by ensuring that the package of nonclinical studies submitted in the application adhere to applicable ICH and FDA guidelines.

Documentation 59

Documentation Drug Development Packaging 59

Pharmaceutical Technology

SEPTEMBER 20, 2022

The information contained within the download document is intended for pharmaceutical manufacturers, wholesalers, retailers and distributors, pharmaceutical executives, medical representatives, business development managers, retail salesmen, sales managers, pharmacy executives, and any other individual involved in pharmaceutical marketing.

Documentation 52

Documentation Pharmaceutical Manufacturing Packaging Pharmaceutical Companies 52

GMPSOP

OCTOBER 26, 2022

According to cGMP, validation in pharmaceutical industry can be defined as “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” Additional documents included each month.

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

GMPSOP

MAY 31, 2024

A validation master plan (VMP) is a strategic document that identifies the elements to validate, the approach to each element, organizational responsibilities, and a strategy for maintaining validation documentation. The VMP should provide information on: – Which items are subject to validation or qualification?

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

pharmaphorum

JUNE 18, 2021

UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for software as a medical device (SaMD). Sheena Macpherson.

Documentation 98

Documentation Packaging Diabetes 98

pharmaphorum

JANUARY 12, 2022

The cobas pulse system is a point-of-care device that combines a glucose test strip reader with a touch screen that is used for displaying patient information and data, as well as analysing and sharing clinical results.

Hospitals 127

Hospitals Packaging Documentation 127

FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. In addition, the final rule requires the submission of product information to the Global Unique Device Identification Data (GUDID).

Labelling 44

Labelling Packaging Documentation 44

RX Note

JUNE 5, 2023

The Hidden Truth Studies have shown that the antineoplastic residues can be found be on the external packaging of both oral and IV drugs. Change gloves every 30 minutes during compounding or immediately when damaged or contaminated, unless otherwise recommended by the manufacturer's documentation.

Compounding 52

Compounding Packaging Hospitals Chemotherapy 52

GMPSOP

FEBRUARY 10, 2024

GMP/GLP and PPE training are applied to all employees, contractors and casual staff working in a GMP environment, including manufacturing, packaging, labelling, distribution, QA, QC, development, validation, engineering, IT staff and anyone whose activities could affect product quality. Additional documents are included each month.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Packaging Compounding 52

GMPSOP

SEPTEMBER 22, 2022

Acceptable Quality Limit is used to make an informed decision whether to accept or reject an incoming packaging components lot by assessing the lot size and types of defects found during a pre-determined level of inspection. To come to a methodical conclusion, the sampling inspector has to know the following information.

Packaging 52

Packaging Documentation Labelling 52

Pharmaceutical Technology

SEPTEMBER 8, 2022

Packaging. • The information contained within the download document is intended for pharmacists, pharmaceutical executives, sales managers, manufacturers, business development managers, pharmaceutical sales representatives, and any other individual involved in the pharmaceutical compounding sector. Excipients. Formulation.

Compounding 52

Compounding Compounding Pharmacies Sterile Compounds Dosage 52

National Association of Boards of Pharmacy

JULY 19, 2024

Know where your current product tracing information (data) is being stored and how to access it. Specifically, they exempt small dispensers from using electronic and interoperable methods for all of the following: Exchanging transaction information and transaction statements with trading partners.

Pharmacy Technician 45

Pharmacy Technician Documentation Communication Packaging 45

GMPSOP

JULY 23, 2023

Installation qualification will provide you with documented evidence that the equipment or system has been designed, developed, supplied, and installed in accordance with design drawings, the supplier’s recommendations, and in-house user requirements. Additional documents included each month. Checkout sample preview s.

Documentation 52

Documentation Method Validation Packaging Labelling 52

GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. – Document control records management and archiving systems. Additional documents included each month. You must document all sampling procedures and plans in use.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

Express Pharma

APRIL 6, 2023

As a result, nutraceutical startups need to stay informed about the latest regulatory changes and requirements in the states where they do business. To achieve this, startups should implement rigorous quality control measures throughout their production processes, from sourcing ingredients to manufacturing and packaging.

Labelling 93

Labelling Dosage Packaging Documentation 93