European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

Packaging 105

Packaging Vaccines Documentation 105

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

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

These efforts included the adoption of a new review template for the assessment and documentation to be used in reviewing NDAs and BLAs with an overall goal of having a more collaborative inter-disciplinary approach to the process. There are those who are willing to read through the more extensive package consisting of all the reviews.

Documentation 57

Documentation Packaging 57

Pharma Pathway

FEBRUARY 22, 2023

-Apply Now @ Bharat Parenterals Limited Department : Regulatory Affairs Qualification: M.Pharm Designation: Officer/ Officer/ Executive/ Senior Executive Experience: 02 to 05 years (Freshers can also Apply) Job Responsibilities: Responsible for Dossier & Documents preparation. Review of the dossiers, DMF & Technical documents.

Documentation 73

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 73

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 100

Packaging Communication Documentation 100

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. – Documented Source Code. Checkout sample preview s.

Documentation 59

Documentation Packaging Communication Pharmaceutical Companies 59

European Pharmaceutical Review

AUGUST 23, 2022

Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively. Overall, validation, documentation and quality control were the major cGMP violations.

Documentation 105

Documentation Pharmaceutical Manufacturing Packaging Labelling 105

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

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintain documentation. All documentation must be kept as supporting evidence. Additional documents included each month. Additional documents included each month. Subscribe a.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintaining documentation. All documentation must be kept as supporting evidence. Additional documents included each month. Additional documents included each month. Subscribe a.

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

Pharma Pathway

JANUARY 10, 2023

M.Tech / Diploma with 0-10 years of experience in below mentioned skill sets: For Biocon BHD: DP Packaging. Required Documents: Resume. Skill Required: If you are M.Sc/ B.Sc / M.Pharm/ B.Pharm/ BE/ B.Tech/ M.E/ DP Filling & Formulations. DP Downstream Manufacturing. DS Upstream Manufacturing. DS Process Engineering & MSAT.

Packaging 67

Packaging Documentation 67

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.” FDA took the right approach balancing the advancement of DSCSA implementation with risk of potential impacts to the flow of medicine.

Packaging 49

Packaging Documentation Pharmacy Technician 49

Quality Matters

NOVEMBER 27, 2023

General Chapters mentioned in the draft guidance Visible particulate matter: USP General Chapter was introduced to address the absence of documents outlining quality test requirements for ophthalmic products and became recognized in USP39. Learn more in a complimentary course “ USP Certificate of Document and Reference Standards.”

Documentation 52

Documentation Packaging Dosage 52

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

European Pharmaceutical Review

JULY 5, 2023

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

Pharmaceutical Manufacturing 96

Pharmaceutical Manufacturing Packaging Documentation Pharmaceutical Companies 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

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. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Checkout sample preview s.

Packaging 59

Packaging Dosage Documentation Labelling 59

European Pharmaceutical Review

DECEMBER 19, 2023

The document was adopted by EMA’s Management Board at its December meeting. AI-supported spectroscopy delivers superior pharmaceutical packaging QC The post European regulators prepare for AI in pharma appeared first on European Pharmaceutical Review.

Packaging 105

Packaging Documentation 105

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 103

Labelling Packaging Documentation Dosage 103

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. – General guidance for validation document format. Additional documents included each month.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

Pharma Pathway

JANUARY 10, 2023

M.Tech / Diploma with 0-10 years of experience in below mentioned skill sets: For Biocon BHD: DP Packaging. Required Documents: Resume. Skill Required: If you are M.Sc/ B.Sc / M.Pharm/ B.Pharm/ BE/ B.Tech/ M.E/ DP Filling & Formulations. DP Downstream Manufacturing. DS Upstream Manufacturing. DS Process Engineering & MSAT.

Packaging 52

Packaging Documentation 52

Pharma Pathway

JANUARY 10, 2023

M.Tech / Diploma with 0-10 years of experience in below mentioned skill sets: For Biocon BHD: DP Packaging. Required Documents: Resume. Skill Required: If you are M.Sc/ B.Sc / M.Pharm/ B.Pharm/ BE/ B.Tech/ M.E/ DP Filling & Formulations. DP Downstream Manufacturing. DS Upstream Manufacturing. DS Process Engineering & MSAT.

Packaging 52

Packaging Documentation 52

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

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

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

Express Pharma

FEBRUARY 13, 2024

The post FedEx Life Science Center launched in Mumbai appeared first on Express Pharma.

Packaging 82

Packaging Documentation Labelling 82

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

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. Background and scope. The draft guidance is based on Health Canada’s existing legal framework.

Labelling 40

Labelling Documentation Packaging 40

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

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. Additional documents included each month. All written and updated by GMP experts. Checkout sample preview s.

Packaging 52

Packaging Documentation Labelling 52

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 97

Adverse Reactions Packaging Documentation Dosage 97

GMPSOP

JUNE 28, 2024

Additional documents included each month. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. Additional documents included each month. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

GMPSOP

FEBRUARY 28, 2024

Regulatory requirements for cleaning and sanitation in pharmaceuticals For more than a few decades, it has been an essential GMP requirement that all cleaning and sanitation steps in a pharmaceutical plant be documented accurately and validated to prove they work. Additional documents included each month. Checkout sample preview s.

Documentation 98

Documentation Packaging Pharmaceutical Manufacturing Compounding 98

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

Big Molecule Watch

JANUARY 5, 2024

The proposed schedule also provides dates for document discovery and depositions. Three utility patents and five design patents alleged to be infringed by SB15 packaging and syringe cap: U.S. A status conference took place today January 5, 2024 in relation to Regeneron’s emergency motion. Patent Nos. Patent Nos. Design Patent Nos.

Packaging 62

Packaging Biosimilars Documentation 62

Quality Matters

AUGUST 3, 2023

They comprise interconnected webs of local and global ingredient suppliers, manufacturers, packagers, distributors, providers, and regulators. active ingredients, excipients, other raw materials) Packaging materials (e.g., Global supply chains are complex and vulnerable to disruption.

Packaging 52

Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 52