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Pharma Consulting Services

 

Pharmaceutical 

Orion GXP Consulting is a pharmaceutical GMP Consultants service for the UK, Ireland and the EU. Our company has extensive experience in quality and regulatory oversight of pharmaceutical import, production and distribution. Our expertise includes solid and liquid oral formulations, topical creams/ointments, ophthalmic products, aseptic filling and terminally sterile products.

 

We provide the following specialized contracting, staffing, and consulting services to the healthcare industry:

Qualified persons pursuant to Article 48 of Directive 2001/83/EC.

Responsible person according to the EU GDP Guide (2013/C 343/01).

GMP and GDP Mock Inspections, On-Site Audits and Supplier Certification.

Pharmaceutical QMS development, implementation, and integration.

Training in key areas such as root cause analysis, batch testing, auditing, data integrity, and quality risk management.

Pharmaceuticals Assists with MIA and WDA license applications.

Due Diligence and Gap Analysis for Mergers, Acquisitions, and Spinoffs.

 

At Orion GXP Consulting, we can support our pharmaceutical clients when they require additional resources by leveraging our network of industry experts, including statutory roles such as Representative and Import Representative.

The MHRA created the role of Responsible Person (Import) RPi as there is a need to repeat the controls carried out by the EU QP, which is bureaucratic and unnecessary. This allows UK companies to obtain his EU/EEA QP certification and import and import products. Importing publications under a Wholesale Distribution Authorization (WDA).

 

We decided to start the new year with a conversation about the role of RPi and its importance with Nim Tully, our Deputy Director, Principal Consultant/Import Officer and our newest employee.

 

When you started working as an RP/RPi consultant, what surprised you about consulting? And how is it different from working in a full-time position in the industry?

 

Most importantly: I think I was able to provide flexibility not only to my clients but also to myself. It was very interesting to see each client at different stages of the process. Some customers are in the early stages and need to submit claims, while others are already established and require ongoing support.

Additionally, when you work full time for a company, you don't get to see all the other ways of working and the stages the company is at. You are on a journey with this company.

Now we have clients at every stage of the process, and it's very interesting that no two clients are the same. Everyone needs my support in different ways.

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How to make sure your warehouse is OSHA compliant ?

 

 

Obedience is a word with heavy connotations. Especially for anyone who is active in the logistics industry. OHSA compliance is not a bad word, and making sure your warehouse complies with all OSHA regulations and safety laws is not difficult. After all, these laws guarantee the safety of every workplace. Staying in compliance with OSHA regulations does more than just reduce injury rates.

It is estimated that nearly 150,000 people work in more than 7,000 warehouses across the United States. These facilities range in size from a small 2,000 square foot warehouse to a 400,000 square foot industrial facility.

All warehouses, regardless of type, must comply with OSHA safety standards. When a company doesn't follow these standards, some things can happen.

Penalties: OSHA is the federal agency that has the authority to impose penalties. Some of these fines are as high as $30,000. Repeat offenders are also subject to full suspension.

 Injuries: While many companies think about their wallets, the financial impact of employee injuries must also be considered. If a worker's compensation claim is filed and found to be the result of an OSHA violation, additional penalties may arise. Access issues can also damage equipment due to fire, electrical failure, or other manufacturing problems. Many current OSHA standards include maintaining plumbing, electrical and gas safety standards for integrity. When these things happen, it can lead to financial loss or even ruin the entire project due to the inability to work.

 

What are the general guidelines for OSHA warehouse safety?

 One of the misleading facts about OSHA's warehouse standards is that they are all the same.

OSHA regulations are based on the size of the warehouse. Similarly, the number of people working and the type of equipment used are also taken into account. However, there are a few general guidelines that all warehouses from the US must follow on a daily basis. Some of the most common OSHA regulations that are often overlooked by warehouse workers include:

 

Failure of air standards for good air quality

Having roads, floors, surfaces, and storage areas full of debris, power lines, spilled water, or other things can cause it to trip, crash, and trip.

Workplace injuries and employee interruptions during physical work

There are no guards or barriers designed in open docks, loading docks, or open doors near structures higher than four feet from the ground.

The primary purpose of OSHA Compliant warehouse in Noida is to ensure a safe and secure environment.

If you have questions about warehouse compliance with OSHA regulations, or to explore ways to improve warehouse efficiency for supply chain operations, please contact the experts at Redwood Logistics.