Water Testing in Pharmaceuticals: Starting Clean Means Finishing Clean

Water Testing in Pharmaceuticals: Starting Clean Means Finishing Clean

Written By: Matthew Greer, Technical Writer, PSC Biotech®

People need their water to be clean, pure, and free from any threating microbes. This is even more imperative when it comes to pharmaceutical manufacturing, especially with injectable products.  Pharmaceutical grade waters must meet the requirements in their pharmacopoeia monograph, so how do you prove that for your Purified Water, Water for Injection, and other waters?  You have a program to regularly monitor, sample, and test the waters from your water systems.

Sampling collects samples that are uncontaminated by the sampling process from all the designated water system test points within a specific time frame. Sampling begins with getting the right containers for each test you want to perform.   

  • Pyrogen-free polystyrene tubes for Endotoxin
  • Sterile bottles for Bioburden
  • Clean tubes for Total Organic Carbon (TOC) and Conductivity
  • Sterile bottles containers including sodium thiosulfate tablets for coliforms
water testing

Generate your paperwork before collecting the water samples. Identify which outlets need to be sampled.  Prepare your sampling containers.

Label the sample containers.  Labels should contain the sample port identification, the analyst initials, the date of sampling, the time of sampling, and the type of testing that needs to be performed on the sample.

When you enter the area where the sample port is located, don the appropriate personal protective equipment (PPE) to collect the sample e.g., sterile gloves, long sleeve lab coat, safety glasses, heat resistant gloves, if needed.  Remember, Hot Water for Injection is HOT!  If you are wearing heat resistant gloves, wear a pair of sterile gloves over the heat resistant gloves to help maintain the integrity of your clean sample containers.

 

Collect your water samples according to your written, approved procedure.  Your sampling procedure shouldconsider how the water is used from that specific sample point.  For example, if the water will be used directly from the point of use without a hose, sampling must occur directly from the outlet using aseptic technique. Typically, the sample port is turned on and allowed to flush for at least one minute at full flow. Once the sample port is flushed, the samples are collected in the appropriately labeled containers. The lids should be held in a face down manner to help prevent microbial contamination and replaced on the filled sample container as soon as possible in an aseptic manner. 

Ensure the containers are labeled with the port number, time and date of collection, analyst initials, and analysis type.

Once sampling is done, the samples need to be submitted to your Quality Control laboratory and timely tested or properly stored according to USP <1231> and your written, approved procedures.  

Once you get the data, you use it to monitor your water systems.  Track and trend your data.  Analyze your data.  Verify your test results are below your Alert and Action levels.  Look for trends that predict problems with your pharmaceutical water systems. 

Alert your water users so that they are aware of the water system status, good or bad, every day.  You want your water users to know they can use your pharmaceutical grade water because you notify them that your waters meet their specifications and not guess that it is OK. 

If you have water questions, PSC® has answers and help.

PSC Biotech® has the resources and professionals available to ensure that your facility is up to cGMP standards when water testing.  It is our professional services mission and pleasure to assist your team with your water needs.  PSC® is your source for comprehensive services to keep your facility, systems, and processes in a “state of control”.  From training to validation, audit preparedness to equipment rentals and sales, PSC Biotech® has the people with the skills and tools to meet your needs.

Contact us today!

Why is Data Integrity Vital

Why is Data Integrity Vital

Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech Corporation

Data Integrity is a point of emphasis for the US FDA.  That means they will always look at your data integrity program.

FDA expects that your data integrity program assures the accuracy, consistency, and completeness of data throughout a product life cycle, right from the conception of the document until its archival and destruction.  FDA expects that your data and your meta-data (the data about the data) will be ALCOA, that is attributable, legible, contemporaneous, original, and accurate.  When your data and meta-data are also complete, consistent, enduring, and available your meet the ALCOA+ (1-2).  These data integrity principles apply to both paper and electronic records.  Your company needs to develop data integrity systems that assure your data and meta-data are ALCOA+.

The reason why data integrity has become so important in recent years is due to the many cGMP violations that have surfaced involving these issues. These violations usually result in FDA Warning Letters, 483 citations, or other regulatory actions.

Data integrity is a critical step in analysis, strategy, and implementation of any process or system that creates, uses, stores, or retrieves data.  If you cannot maintain integrity of data, you can’t prove to FDA that you can maintain high quality, uniformity in the process, and safety and efficacy of your products.

There are 3 backbones for Data Integrity

  1. A Quality Management System
  2. Sound principles and policies
  3. Good documentation practices (GDP)

Your company should adhere to basic Data Integrity practices.

  1. Ensure data is documented at the time of performance.
  2. Implement a quality compliant culture within the company.
  3. Train personnel involved in the processes to timely record data at every step in a product life-cycle.
  4. Make sure that all data recorded is complete and accurate.
  5. Make sure that documents are stored as “true copies” or “original records” or “effective versions”.
  6. Ensure that there are systems (paper or electronic) in place to store true copies or records that indicate the current protocol or process being followed in the company.
  7. Store data and meta-data to prevent deterioration or loss. While paper systems are also used by many companies for storage of data, electronic systems are the most beneficial when it comes to storing data in the desired format, easy accessibility, centralized database, as well as proper archival.
  8. Store backup data in its exact and complete form.
  9. Ensure stored data is secure from any sort of alteration, erasure, or loss.
  10. If you use an electronic system, use a validated electronic system or validate your electronic system. Electronic systems make it easy to create, edit, process, store, retrieve, and archive data, with a full 21 CFR Part 11 complaint audit trail to track activity.

Sound data integrity policies and systems ensure that companies deliver good quality, safe and reliable product with lowest rate of variation.

PSC Software™ has software solutions such as ACE® (Adaptive Compliance Engine®) and ACE Essentials™ that are fully integrated, validated, and fully configurable electronic Quality Management Systems that give you data integrity and adapt to how you run your quality systems and business.  Life-science companies across many countries use PSC Software products to implement data integrity principles and maintain regulatory compliance.

Call us today to explore the right solution for your needs.

References

  1. FDA, Data Integrity and Compliance with CGMP, Guidance for Industry
  2. World Health Organization: Guideline on Data Integrity
  3. 21 CFR (Code of Federal Regulations) Part 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs), Part 211 (Current Good Manufacturing Practice on Finished Pharmaceuticals), Part 212 (Current Good Manufacturing Practice for Positron Emission Tomography Drugs)
The Importance of Good Documentation Practices

The Importance of Good Documentation Practices

Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®

Documentation is a “record” or “evidence” of an event that has happened. In the life-science industry “If it isn’t documented, it didn’t happen”. Good Documentation Practices (GDP) are how you prove it happened.

Regulatory Agencies across the world stress the importance of Good Documentation Practices through various laws, regulations, and guidance documents. Good Documentation Practices are a key aspect of a good quality management system. GDP is also an effective way to avoid your company getting Warning Letters or 483 citations. GDP is applicable for all industries, not just those that manufacture regulated products such as drugs, medical devices, biologics, cosmetic, food products.

GDP can be implemented in different ways, some of the most common methods are:

1) Ensure all the processes are documented in a clear manner with data that is reliable and accurate: GPD practices run on the very widely followed concept called ALCOA, processes that assure that your data is Attributable, Legible, Contemporaneous, Original and Accurate. Management need to assess the capabilities of the company and implement documentation practices that accurately reflect their processes and perform in a reproducible and consistent manner.

2) Tracking Changes and Reporting Deviations: You must report, investigate, and resolve changes or deviations in your process. Good documentation practices helps to track changes, ensures easy reporting of any defects as well as promote continuous improvements to the processes that can be recorded real time.

3) Robust Electronic System to Replace Paper: You can do GDP on paper. It is so much easier with a validated electronic quality management system.  You can develop systems that can collect, process, and maintain the vast array of data, reports, protocols and all other documentation that is proof of their quality standards. Such systems also help maintain an audit trail, enable electronic signatures and tracking of approval of various documents real-time.

Good Documentation Practices

4) Archival of documents: A record you can’t keep isn’t a record. Various regulations and guidance documents address proper archival of records. Remember, if it isn’t documented or you can’t find the record, it didn’t happen!

5) Training Personnel: Train your personnel on GDP. It is essential to implement a quality compliant culture within your company. An electronic Quality Management System can also do and document your training.

6) Centralized Database for all relevant stakeholders: A centralized database for all stakeholders involved with the process such as suppliers, vendors, manufacturers, quality assurance personnel, regulatory affairs team, while also making it easy for companies to maintain one system for all their process requirements.

PSC’s® software solutions such as ACE® (Adaptive Compliance Engine®) and ACE Essentials™ are fully integrated, validated, centralized electronic Quality Management Systems that have been helping many life- science companies on all the essential aspects of GDP.

GDP is one of the first few critical steps in implementing a robust quality management system that ensures that your company delivers high quality products in a consistent manner.

Guidance documents for reference:

ICH Q7 guideline: Good Manufacturing Practices for Active Pharmaceutical Ingredients

Annex 5: World Health Organization, Guidance on good data and record management practices

If you need assistance with executing GDP and more details on PSC Software solutions, ACE® and ACE Essentials™, please contact PSC Biotech at sales@biotech.com.

Calibration Management Made Easy

Calibration Management Made Easy

Written By: Chandler Conley, Business Development Manager

Accuracy of equipment for testing and measurement is necessary for developing and manufacturing critical products, pharmaceuticals, medical devices and more. If you have a well-organized calibration program, you minimize your risk of using out of tolerance equipment. Oh yes, your calibration program prevents FDA 483 citations.  Failure to perform calibration, inspection, and checking ranked at number 9 of the top 15 deficiencies in 2014.  Related citations include absence of written protocols, failure to follow written procedures, and the absence of scientifically sound laboratory controls.

You need to decide which pieces of equipment need to be calibrated and how often they need calibration. The obvious list includes critical equipment used for product approval, sensors used for qualifications, and equipment that is used to assure processes are performing as needed.  You also need to consider equipment in your indirect and utility systems.  A comprehensive asset list with calibration due dates, calibration parameters, and processes makes calibration program management easier.  PSC Software™’s (ACE™) electronic Quality Management System provides an integrated quality solution that can manage you calibration program and seamlessly integrate it into your quality system.

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Your “smart” equipment may be able to alert you that calibration is due, such as the Lives International XpertLog thermal validation systems and wireless data loggers, where you can restrict sensor operation if calibration is overdue, or the CLiMET Instruments lines of particle counters, which can be set to not operate if the current calibration has expired. These “smart” instruments add ways to prevent use when calibration has expired. Calibration stickers with due dates on equipment may eventually fall off or wear down on equipment that is cleaned frequently. They also may be in areas that are not obviously visible to users, so built in lock-outs or restrictions are a great backup plan.

If you need support from experts in developing or supporting your calibration program, need  metrology and calibration services, ACE software, or CLiMET Instruments and Lives International equipment sales, please contact PSC Biotech at sales@biotech.com!

Professional Technical Writing Services

Professional Technical Writing Services

We Have Technical Writers Trained in Good Documentation Practices

There’s an industry event happening and you have been invited to present a whitepaper. Now, you need someone who can write the whitepaper for you. You need someone with the appropriate technological literacy.

Someone who can understand and elaborate on, for example, why your latest innovation changes lives and craft a compelling, persuasive paper that will grip your readers.

When you hire PSC – that’s the kind of balance we provide on a daily basis. Our highly educated and experienced team members have technical writing experience on various topics.

Wide Array of Experiences

From Global Harmonization to Regulatory Affairs – our writers have written on anything you can imagine. This means – whenever you hire us, our writers will ask questions from your designated subject matter experts (SMEs).

Gauging the right information enables our team to produce the excellent quality that you need. When our team has gathered all the data, we’ll be able to create all kinds of content. Our team consists of experts in:

  • Drafting
  • Editing

And reviewing technical documents such as:

  • Protocols
  • Summary Reports
  • Specifications
  • SOPs (Standard Operating Procedures)
  • Manuals

Here’s How You Can Go Wrong With Technical Writing

Many mid-sized engineering, startups, high-technology, and manufacturing companies don’t have a technical writer in their staff. So, whenever there is a need to write a technical document, who do you assign to write the document?

Do you assign the duty of documentation to the project’s engineer, marketing communications team member or a technician in the company?  Business owners sometimes forget that writing is a skill in itself. Knowing a great deal about something doesn’t ensure that you’ll write well about it, too.

Even when businesses decide to hire a technical writer, they can make another crucial mistake. Since “price” is often the only priority, managers hire the cheapest resource which often leads them to hires the wrong resource. No one ever considers hiring a technical writing professional to write it right.  Businesses often end up with a writer who isn’t experienced or has the wrong skill set. Here’s why:

  • Everyone in your company has tasks of their own.
  • You can’t expect professional work from a non-professional.
  • Getting quality work at bargain prices is hard, and sometimes impossible.

Why You Need A Professional Technical Writer

A professional technical writer is well worth the money you spend. This can especially be true if you’re hiring a technical writer for a specific task.

Here are three reasons you should always hire a professional technical writing service:

  1. A professional technical writer devotes all of their time to your project. You can’t expect the same when you designate a writing task to an internal employee since they’re going to have work of their own, too.
  2. A technical writer is an expert on evaluating the content strategy, timeline and plan. That is why they are able to deliver on time
  3. Technical writers are aware of all the tools they can use to create content for you. Because of the tools they have access to, they are able to create content that is unmatchable and unique.

To hire us for your technical writing service needs, contact us today or click here to know more.

Why Hire Consultants for Process Safety Evaluations and Lock-Out/Tag-Out in the Life Sciences Industry?

Why Hire Consultants for Process Safety Evaluations and Lock-Out/Tag-Out in the Life Sciences Industry?

Process Safety Evaluations

Process Safety Evaluation Consultants provide the insight and recommendations to enable enterprises in the life sciences industry to safely scale-up their development work and operate their manufacturing processes with mitigated risks. In the tightly regulated healthcare space, Process Safety Evaluation professionals ensure compliance while reducing operational risks and the probability of incidents.

How do Consultants Evaluate Process Safety?

Process Safety Evaluation consultants do their evaluation on-site or in their certified Process safety laboratory in a comprehensive and data-driven manner.  The process safety report presents recommendations to eliminate or mitigate identified risks in your healthcare operations.

What is Evaluated in Process Safety?

Process Safety Evaluation identifies the hazards and control measures including, but not limited to the following process areas.

  • Properties of raw material and reaction mixtures
  • Properties of intermediary and final products
  • Thermal Stability of material and equipment
  • Quantity, order of addition of reactants, and the rate of heat generation
  • Pressure and gas systems evaluation
  • Flammability
  • Combustible dusts or vapors
  • Chemical or biological hazards

The Process Safety Evaluation report contains the test results and evaluations of the process, recommendations, and the ‘Basis of Safe’ (BOS) operating ranges that you should apply to your Research, Development, Scale-up, Pilot Scale, Clinical, and Full-Scale Commercial manufacturing operations.

Lock-Out/Tag-Out (LOTO) Development

Equipment and machines always have some form of ‘Hazardous Energy’ associated with them and they all need cleaning and maintenance.  Lock-Out/Tag-Out procedures are the way that you assure that no one, even the personnel not directly involved in the cleaning or maintenance of the equipment, is injured when people are working on the equipment.

Electricity is not the Only ‘Hazardous Energy’

Hazardous energies include;

  • Mechanical
  • Chemical
  • Hydraulic
  • Electrical
  • Thermal
  • Pneumatic
  • Radiation

How do you Develop a LOTO Procedure?

You develop your Lock-Out/Tag-Out procedures as part of your an industrial safety evaluation performed by experienced consultants or your Environmental, Health, and Safety (EH&S) staff. A LOTO procedure involves the specific steps and training of your staff, contractors, and vendor personnel to use the proper locks and tags, the step-by-step process for installing them, verifying that the equipment is deenergized and safe for work, and the step-by-step process to safely clear the equipment and return the equipment to an energized state.

Process safety evaluations and LOTO save the lives of your staff, keep your workplace safe , and save you the monetary, legal and regulatory penalties that come with worker injuries or deaths.  Hiring the right Safety Consultants is always a wise investment, especially if you are planning to install new equipment, scale-up production, or revamp your operations. PSC Biotech provides engineering safety and associated services consultants to make your company operations safer and more efficient.

Connect with us now at https://biotech.com/contact-us/

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