USP 800

The United States Pharmacopeial Convention (USP) is looking into the establishment of safety standards to be used when handling drugs that are considered hazardous. While there are other organizations that have provided standards on handling hazardous drugs, USP 800 addresses in detail the storage, transportation, handling, compounding, administration as well as disposal of hazardous drugs. The following are the objectives USP 800 is seeking to meet.

-        Protect both the involved personnel as well as the general environment.

-        Proper handling of hazardous drugs.

-        Handling of both sterile and non-sterile product preparation.

-        Implementing all required standards.

To be more specific, USP 800 refers to the primary and secondary containment engineering controls which are in relation to the storage and compounding of HDs. It therefore addresses the guidelines on facility design, engineering controls, personal protective equipment as well as transportation of hazardous drugs.

Engineering Controls, Facility Design and Compounding

It identifies the primary and secondary containment engineering controls, Containment Primary Engineering Control (C-PEC) and Containment Secondary Engineering Control (C-SEC) which are in relation to the storage and compounding of HDs. The C-PECs are devices that are ventilated to reduce the risks of the workers and the environment from hazardous drugs. C-PECs there include equipment such as:

-        Biological Safety cabinets (BSC).

-        Compounding aseptic containment isolators (CASIs).

-        Containment ventilated enclosures (CVEs).

On the other hand, the C-SEC is the room in which the containment primary engineering control devices are kept. The rooms are negative pressure which are ventilated externally. The rooms may come with a refrigerator in case there are some hazardous drugs that require refrigeration. Depending on the drug, you will be pushed to controlling air changes per hour (ACPH). In this, it is evident that different hazardous drugs. There should be different areas designated for different drug conditions.

The different engineering controls fulfill the desired standards. The engineering controls for non-sterile HDs and those for sterile HD compounding are different. Therefore, you need a professional who understands the USP 800 chapter to put all the requirements in place. Every requirement must be fulfilled to the very last bit and you need to meet them.

Personal Protective Equipment and Personnel Training

It is not a compromise that all personnel must be in protective gear at all times when handling hazardous drugs. Every protective gear is outlined in the USP 800 and its use fully described to ensure that the company's personnel is safe.

In addition, each institution for this category is required to offer a training program that highlights what they are up against when handling hazardous drugs and their contents. All the procedures regarding storage, handling, as well as disposal must be well known to all personnel. After the training, the staff should be assessed of their competency from time to time to minimize on safety risks.

The above services cannot be complete and met without ensuring that all standards are met. In this, professionalism and a better understanding of this chapter must be looked into help implement the required requirements. 

cGMP Compliance Services - 21 CFR Parts 210 & 211

The Current Good Manufacturing Practice (cGMP) compliance services are a must in the pharmaceutical industry. You must adhere to 21 CFR PART 210 and 211 in an effort to determine FDA compliance with the GMP regulations for the production of pharmaceutical products. In the event that any of the standards are not implemented, the company in question will face disruptive regulatory action.

Parts 210 indicates the minimum Good Manufacturing Practices through the manufacturing, processing, packing and handling of all drugs under the FDA purview. On the other hand, section 211 is more specific to outline the GMP requirements of the finished pharmaceuticals. In the event that there are conflicting requirements, the general requirements are superseded by the drug-specific GMP requirements. With the help of a professional, understanding all the necessary requirements becomes easier and there is a sense of security that all the requirements are met.

Part 211 covers a wider variety of features that must be addressed including the personnel in question, the facilities and equipment in use, the production processes, as well as the stability testing and the labeling of products. The “what” is a specific compliance that none of the manufacturers can alter. However, how the manufacturers choose to go about it is determined by each of them as individuals. In this, there is need to develop product-specific as well as the need for validation processes.

When a manufacturer creates and consistently follows all the procedures as well as document them, they get to determine if GMP compliance has been met by reference to 21 CFR Part 211 requirements. Looking at the procedures, it is evident that the more complex the procedures, the more the input that is required. In this, you will use more resources and spend more of your time to ensure and prove compliance of this part.

Determining Actionable vs. Non-binding Recommendations

The FDA will on a regular basis offer a draft copy and the final documents that will detail the cGMP depending on the product in question or in reference to a given product category. For example, the Current Good Manufacturing Practice for Medical Gases was included in draft form in the year 2003, May.

In every clause, individuals must understand the use of the terms “must” and “should” in an effort to determine the difference between the legally enforceable GMP and the non-binding recommendations. With the help of the right expertise, you need not worry about the determinations. All the terms and requirements will be met as expected and on time.

It is possible that when you are looking for some given requirements, you can easily check with the Code of Federal Regulations. However, it is not as simple as this as there are many additional clauses that look to make a few aspects more specific. Implementation that will bring about success is far much complicated. The perspective of an expert comes in handy. With the right experts who have accumulated experience must be sought after. Seek cGMP Compliance Services - 21 CFR Parts 210 & 211 to fulfill company requirements.