GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed effectiveness, and communicated to a larger audience. All documentation must be kept as supporting evidence.

Documentation 52

Documentation Packaging Communication Customer Service 52

pharmaphorum

OCTOBER 27, 2022

The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.

Communication 97

Communication Pharmaceutical Manufacturing Packaging Documentation 97

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

Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

FDA Law Blog: Biosimilars

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. When referencing documents within the AI response, cite location within the 510(k) supplement (e.g.,

Documentation 75

Documentation Packaging Communication Labelling 75

GMPSOP

AUGUST 28, 2023

Raw materials must be inspected to confirm that the containers are intact, have been provided according to the paperwork, and have labels affixed on them identifying the raw material name, batch number, and expiry date. For example, materials with Hold, Quarantine, or Rejected labels must be kept in a quarantine location.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Documentation 52

GMPSOP

AUGUST 23, 2022

Assessing the impact of changes to a process/system The use of quality risk management and the methodology to be used should be documented in the relevant validation plan or change management procedure. Additional documents included each month. process change, product recall, labelling change, adverse event/safety reporting)?

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

Documentation 45

Documentation Labelling Communication 45

GMPSOP

JULY 14, 2023

Additional documents included each month. Additional documents included each month. Cleaning requirements for dedicated equipment may be less than those for common equipment, provided the company has documented either the maximum number of batches or the maximum time that can elapse before complete cleaning must be done.

Documentation 52

Documentation Labelling Pharmaceutical Manufacturing Packaging 52

GMPSOP

NOVEMBER 6, 2022

Additional documents included each month. After the preparation secondary reference standards are tested for potency, labelled, dated and stored, handled and used in testing so as not prejudice quality. d) When the reference standard is first opened, an “opened date” must be written on the label of the vial.

Labelling 52

Labelling Documentation Packaging Communication 52

Quality Matters

AUGUST 3, 2023

ampules, bottles, labels, cartons, shipping containers, desiccants) Services (e.g., This risk assessment effort is not a one-time event but rather a periodic, recurring process for communicating and reviewing risks,” noted USP’s Horacio Pappa, Ph.D., active ingredients, excipients, other raw materials) Packaging materials (e.g.,

Packaging 52

Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 52

GMPSOP

MARCH 17, 2023

Immediately communicate the incident to stakeholders and initiate an internal laboratory investigation. Additional documents included each month. – Status control: implementing status labels to clearly identify workflow status such as issues, returns, rejects and reworks of components to prevent mix ups.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

Eye on FDA

AUGUST 18, 2020

But it is not likely to surprise anyone that the first half of 2020 has caused not only an increase in communication from FDA, but a focus as well. The agency sent out 9 alerts during the first half of the year, 4 of which were related to COVID-19, including one for the off-label use of anti-malaria medications.

Communication 61

Communication Documentation Labelling 61

GMPSOP

MARCH 20, 2024

Additional documents included each month. Additional documents included each month. You should identify and document the instrument ID, date and time of calibration, units of measurement, the standards used, the steps taken during calibration, and environmental conditions. Additional documents included each month.

Documentation 52

Documentation Pharmaceutical Manufacturing Labelling Communication 52

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

Packaging 59

Packaging Documentation Labelling Communication 59

pharmaphorum

SEPTEMBER 15, 2020

The huge rise in the use of telemedicine services during lockdown has brought care directly to patients in their homes, while pharma’s communications with healthcare professionals (HCPs) has experienced a similar push to digital channels. The mindset that accomplished this needs to be retained,” Jeremy says. About the interviewees.

Communication 123

Communication Documentation Labelling Vaccines 123

European Pharmaceutical Review

NOVEMBER 24, 2022

These include Meditag serialised hologram labels, first introduced in 2005 and found on all registered medicines in Malaysia to help pharmacists and inspectors detect unauthorised and counterfeit product. Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

Packaging 95

Packaging Labelling Documentation Dosage 95

pharmaphorum

OCTOBER 6, 2020

Apply Data: Regulatory employees should be using stored data to intelligently create submission documents. By limiting documents full of free text fields and subjectivity companies can adopt a more digitised approach, where document templates can be compiled automatically from available data. Label Authoring and Tracking.

Documentation 111

Documentation Communication Labelling Data Entry 111

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

Eye on FDA

JULY 7, 2020

In the now distant past, enforcement from this office, then called the Division of Drug Marketing, Advertising, and Communications (DDMAC) and later re-named OPDP, was robust, with the office issuing scores of letters a year (156 were issued in 1998). One of them was about the appropriate use of links.

Communication 52

Communication Documentation Labelling Pharmaceutical Companies 52

GMPSOP

MARCH 4, 2023

Additional documents included each month. 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. Additional documents included each month. Checkout sample preview s.

Documentation 52

Documentation Communication Method Validation Packaging 52

GMPSOP

JULY 31, 2023

These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results. Installation qualification verifies and documents that all critical aspects of equipment installation adhere to predetermined specifications and manufacturer’s recommendations.

Documentation 52

Documentation Dosage Labelling Data Entry 52

pharmaphorum

OCTOBER 4, 2022

The FDA explains that regardless of the complexity of the software and whether or not the software is proprietary, the output or labelling should provide HCP users with adequate background information in plain language on the input(s), algorithm logic or methods, datasets, and validation. Criteria for regulation.

Documentation 105

Documentation Labelling Communication 105

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night. Human Touch - Why Artificial Intelligence cannot replace us still? Theory in Practice - Life is not ideal but a struggle Life - Why?

HIV Treatment and Prevention Agents 75

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 75

Pharmaceutical Technology

JUNE 19, 2023

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.

Labelling 52

Labelling Packaging Documentation Dosage 52

Pharmaceutical Technology

APRIL 26, 2023

The document contains detailed information on the providers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Furthermore, the rising demand for sustainable packaging solutions is gradually opening a new avenue in the primary packaging market.

Packaging 52

Packaging Documentation Communication Labelling 52

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. Please check your email to download the Report.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

Dosage 83

Dosage Documentation Diabetes Labelling 83

The Thyroid Pharmacist

JANUARY 20, 2023

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In Holy Basil ( Ocimum sanctum ) The anti-inflammatory effects of holy basil (also known as tulsi) have been documented in many in vitro and in vivo studies. Exp Toxicol Pathol. Exp Toxicol Pathol.

HIV Treatment and Prevention Agents 90

HIV Treatment and Prevention Agents Diabetes Immunity Immunization 90