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Certificates of Analysis (COA)

A Certificate of Analysis (COA) is a document that NEUTRON PHARMACHEMICAL CO. produce that verifies the product they manufactured conforms to their customer’s requirements. It is important for the customers to know that the product they are receiving adheres to their specific parameters and targets, and to ensure that it meets their needs. COAs help your company prevent costly returns, replacements, or customer complaints. In this article, we will discuss exactly why COAs are so important and the best way to manage them within your company.

What makes up a COA document?

The Food and Drug Administration (FDA) lists specific requirements for each COA document your company produce. These include;

  • Supplier Information: This section contains data regarding the material supplier, including their name, address, and other contact information.

  • Materials Identification: The content in this section identifies the material being verified by this COA. And it usually contains common terms such as lot numbers, product codes and descriptions.

  • Transportation Data: This area generally includes the customer name and address, original purchase order, or other details such as the item’s destination. This content is provided to meet shipping requirements and to help the receiver in confirming the material is authorized and its delivery is anticipated.

  • Evidence of Conformance: This section holds the most important information in the COA. It states the specific characteristics, test results or other evidence in terms of industry standards, regulatory requirements or customer-specific request. In some cases, the performance standards expected will also be noted for reference.

  • Signature Data: This last section of the COA includes a signature indicating that the evidence presented was reviewed by a qualified and authorized product inspector.

 Without each of these sections and data, your COA will not count as a legitimate inspection of your product, and you may run into legal or business ramifications.

What are COAs used for?

As previously mentioned, COAs are documents meant to prove the products you are manufacturing are up to your customers’ expectations. With countless items being produced by manufacturers, it is often difficult for a company to seamlessly track materials from the very beginning to the end of the final product process. This means that companies rely more and more on their suppliers to provide quality materials for finished products.

A COA goes beyond just acting as a product inspection as well. With materials rapidly moving to and from different locations, it is necessary to have the shipped material clearly and correctly identified and clarified. In addition to material and container labels, the COA serves as an identification document for the status of each product. These documents provide more detailed information than a label generally provides. The COA conveys information from a material supplier to a material user about the identity, quality, and purity of that specific material. It is very important for a material supplier to show its customer a trustworthy COA so that the customer can understand exactly what type of product they receive. The receiver can also compare the information provided on the vendor’s COA against its specifications to see whether the material meets the required criteria.

Why does our company need to produce COAs?

Many manufacturers know there are advantages to creating COAs but consider them too costly and time-consuming. However, without producing a trustworthy and accurate COA, your company could face both business and legal consequences. These include, but are not limited to;

  • Decreased confidence in what gets shipped out

  • Increase in product recalls, wasting company time and money

  • Audit process becomes more complicated

  • Competitors can get the edge when they produce COAs and you do not

  • Lost customers

The price of not having COAs is quite high, much higher than the cost to produce COAs in the first place. Without these documents, your company could very likely lose money, customers, and even credibility within your industry. While the process to begin creating and distributing COAs may seem daunting, a document management system (DMS) can help.

How Should You Manage Them?

As important as COAs are for companies who manufacture products, it can be challenging to figure out how best to collaborate on and organize them. If you opt to manage them manually, with a paper system, you are increasing the likelihood of human error and losing vital business efficiency. However, with a document management system (DMS) like ENSUR, you are provided a central location for all your COAs. Using a DMS, your company can realize the following benefits:

  • Control the COAs you create and send to your customers using the  version control

  • Easily distribute COAs with overlays, form reports, address book/contact distribution, and publishing to external locations like file shares

  • Configure your content types using default routing and LOT numbering

  • Structured data that allows for field-based searching, exporting, and reporting

  • Use of concept of “Master COAs” to lock data that COA editors should not be editing 

Standard Operating Procedure (SOP),Working Instruction (WI)

Standard Operating Procedure (SOP) is a set of written instructions that shows how to perform a routine activity in an organization. The development and use of SOPs form an integral part of any successful quality system. Standard operating procedures (SOP) is useful and effective for every organization as it will state all the tasks that are essential for business success, the steps to do tasks and the person-in-charge of each tasks. It helps to improve business productivity.

While many misunderstand it as writing your biodata in an essay form, it is, in fact, more formal, organized and targeted. Due to such nonchalance, many students, even those with great potential, lose good opportunities simply because they were too cocky or careless about SOP.

Why Are SOPs So Important?

SOPs are a primary way to implement or enforce a policy. Policies are intended to steer an organization to achieve the mission, vision, and goals of an organization, but without SOPs, are not actionable. SOPs also encourage consistency in execution, which is critical for demonstrating compliance with or achievement of targets described in a service level agreement.

Challenges in Writing SOPs

One of the most significant challenges in writing SOPs is that there are no hard and fast rules for writing them. A format or writing style that works for one organization may not work as well with another organization.

Secondly, SOPs can become out of date very quickly if not regularly maintained. The business is ever-changing and evolving, and as a result, IT changes and evolves as well. If SOPs aren’t maintained as part of those changes, they will become obsolete.

5 Things to Consider When Writing SOPs

While there is no right or wrong way to write an SOP, there are several things that you must consider when writing an SOP. SOPs must be:

This means legible font sizes, numbered pages, titles, numbered paragraph headings, and effective use of whitespace.

Using a template or predefined format makes the content easy to read.

To be effective, SOPs must be focused and to the point, using relevant, but simple terms.

SOPs must clearly and succinctly describe what is to be done.

The activities described within an SOP must be specific and measurable.

Here Are the Steps to Ensure That You Write A Good SOP

1.Give it a storyline

One tip which can ensure that your SOP is interesting and does not sound like monotonous statements is to give your SOP a storyline to make it engage. However, certain things you must keep in mind – giving the texture of a story does not mean that you loosen the ends on your writing and engage in a very casual, informal method of expression. Also refrain from using slangs or colloquial words. You can write a good story using a refined language, tone and attitude.

2. Be Forthcoming About Yourself

It is advised that you put down your details honestly. You should not hesitate in talking about any problems which might have affected your academic or work life in the past and that you would ensure that these problems do not affect your time at the institution applied for (in case, selected). Make sure you write down how you managed to deal with the problem and what you learned from it.

3. But, above all, refrain from lies.

You must make the reviewers believe in you. One way of doing so is by inputting little details about it, aside from the more prominent ones. The idea is to give the impression that you have researched extensively and know enough about it to inspire confidence in your choice.

4. Be Very Specific and Focused

Do not go astray while writing down the SOP. Ensure that you are specific and focused in every detail that you give.

5. Proofread

Even if you are cent percent confident about your writing abilities, it is highly advised that you proofread the SOP as many times as you can. Also, consider getting it reviewed from persons who have written successful SOPs or are very good at reviewing and editing.

Ready, Set, Write that SOP!

Writing SOPs is often considered a mundane, tedious job, but it doesn’t have to be.  An effective SOP depends on several factors, like readability, understandability, and measurability, but it doesn’t have to be an

Badget Text

Material safety data sheet (MSDS)

Another very important aspect to watch for are SDS red flags. When it comes to safety data or hazardous substances, red flags should never be ignored nor underestimated, . . .

Material safety data sheet (MSDS), Safety Data Sheet (SDS)

Another very important aspect to watch for are SDS red flags. When it comes to safety data or hazardous substances, red flags should never be ignored nor underestimated. This is especially true of items that fall under the category of different types of clinical waste, whether it comes from the cancer treatment center or from the housekeepers of your hospital. Some chemical substances found in hospital or any medical setting environment can:

  • Effect and damage mucous membranes, skin, the eyes, or if inhaled, the lungs.

  • React with water. Some substances containing chemicals that react with water do so violently, often producing dangerous vapors.

It doesn’t matter whether your veterinary practice, a cancer treatment center, a medical waste business, or a hospital. Healthcare waste segregation is essential in properly categorizing, separating, handling, storage, and transportation as well as ultimate disposal of potentially dangerous substances.

Safety data sheets are all about safety and moving forward in a culture of safety within a business or healthcare environment. In most cases, safety data sheets prevent exposure to hazardous materials, especially those involving chemicals. Read them!

A number of caustic chemicals are found within the healthcare industry, from cleaning fluids to chemotherapy drugs. Adequate healthcare waste management that adheres to regulations and guidelines pertaining to safety are important.

Do your employees, from janitorial and housekeeping staff to healthcare professionals involved in cancer treatments or other medical treatments that may be even slightly exposed to hazardous substances know how to deal with them? If not, training is recommended.


Who creates MSDS sheets?


Who creates MSDS sheets? The Occupational Safety and Health Administration (OSHA) routinely updates their 
safety data sheets.  OSHA doesn’t regulate hazardous waste, so you may think that safety data sheets are not applicable to medical or healthcare settings. In general, safety data sheets are provided with dangerous chemicals, although some exceptions are made for certain types of chemicals that are not specifically classified as dangerous.

Actually, the Code of Federal Regulations (29 CFR 1910.1200) is the federal law that explains the topic fully. While finding this codes may seem daunting, Daniels Health actually has a Compliance Portal that makes it easy. Our system allows you to search for millions of SDSs by product name or manufacturer. You can even upload your own SDSs – we make going digital easy.

 

A number of companies, including those producing pharmaceuticals, may send along safety data sheets with chemical products. In such cases, the safety data sheet will contain:

  • Identification of the product, its recommended uses and restrictions, and information regarding the supplier as well as emergency telephone numbers.

  • A section identifying hazards, such as its classification hazard. Categories are ranked based on the potential hazards associated with the product. For example, these categories can warn against serious eye damage or eye irritation. It also defines possible skin irritation or corrosion. It may have the potential to produce acute toxicity in liquid form, or acute toxicity in oral form.

  • Hazard statements found on safety data sheets will state what can happen in certain circumstances. For example, “harmful if swallowed” or “may be harmful in contact with skin” or even worse, “causes severe skin burns and eye damage”.

  • Precautionary statements are also found on safety data sheets such as this in order to prevent accidents. Suggestions such as wearing protective gloves and eye protection, not smoking around the product, not breathing in sprays or mists, and so forth.