I’ve been in Denver for about 6 months now. It’s an awesome place where I keep meeting more and more people in the industry. If you’re looking to get into the industry, this is the place to be, if you’ve got the hustle.

I had the pleasure of meeting a fellow chemist, master grower, and consultant, Christopher Sloper a few weeks ago. He came in to advise on some issues at a site I’m working at, and he brought along a few copies of his book, “The LED Grow Book – Better. Easier. Less Watts.”

In Christopher’s book, he describes LED lights, how they work, why they work, and finally how to work with them. His book, however, goes much further than that as he explains his growing philosophy.

The book focuses on the basics to successfully cultivate cannabis under LED lights. His Good Gardening Practices (GGP) set the tone of his methods.

The reasons why LED Lights are a win:

LED lights can be designed to drive photosynthesis and photomorphogenesis to levels greater than HPS while using much less watts.

Not only can LED lights deliver the proper PAR (photosynthetically active radiation) levels for plants, they also distribute the light properly by focusing the light downward, rather than in all directions. This reduces the wasted photons scattered into the open environment, and focuses the light on the plants.

LEDs dramatically reduce the amount of energy used compared to old High Intensity Discharge technology. Add in that the cost of electricity is only going up, and you again seal another reason to go LED.

LEDs are easy to use because of their low heat emissions, and take away the need to use expensive and cumbersome air conditioning units. A huge win!

Myths about LED Grow Lights

Christopher busts down the myth that lumens are proportional to photosynthesis.  To be clear, photosynthesis is directly related to the number of photons the plants receive. Christopher describes the concept of PPFD (photosynthetic photo flux density) which is the proper way to describe how many PAR photons are hitting a given surface of plant at any point in time.

Christopher busts several other myths about the perceived benefits of LEDs and clarifies arguments both for and against the new technology.

How LED Grow Lights work

Christopher explains the exact mechanics of how an LED emitter works. From the point of power going into device, to how photons are released, to how those photons are focused towards the plants, the explanation sets up the understanding for how LEDs function.

Christopher goes on to discuss how LEDs can be controlled. They produce less heat because they don’t operate in the Infrared (IR) region of the light spectrum. This leads to discussing if LEDs need tunable spectrums, and how this changes the need for gardeners to optimize the height of the light relative to the canopy.

LEDs do not put out the same amount of heat to generate the same light levels as other technologies, and therefore greatly reduce one of the most important considerations for properly controlling the growing environment – air conditioning.  This saves energy and major complications of installing expensive systems that may only be used for a short amount of time.

Safety also hits the radar with LED lights – the chance of killing your garden due to overheating caused by failed ventilation or air conditioning is greatly reduced, not to mention the chance of burning your operation down due to fire.

LEDs and Photosynthesis

This section is where a chemist or biochemist can geek out, where it’s explained how photosynthesis works when using LED grow lights. He explains the chemistry of photosynthesis, how the different light waves affect the photoperiod and light signaling for inducing flowering as well as the growth characteristics.

Choosing an LED Light

This is where it gets into all the details you must consider when choosing an LED light. This is a very important section, and I hope all readers would pay close attention to it. Making the right choices here will greatly improve your chances of success.

The first consideration is the size of your garden, and your gardening goals. Are you a hobbyist, small commercial, or large commercial gardener?

Next up, what wavelengths do you need? Depending on your needs, you can focus on specific light absorbing molecules within the plant, and thereby increase different growth characteristics. This is an essential question for truly dialing in the growth of your plants – are you trying to veg the strongest plants, or grow out the biggest possible buds? This section alone may be worth the cost of book.

Downstream considerations look into the physical construction of the LEDs. What is the beam angle that best serves your gardening needs? 90˚ or 45˚? Tall plants, or short plants?

Heat is still an issue with LEDs – you’re running electricity into a box that converts it to light, and no device is able to turn all that energy into light – some of it will be converted to heat energy. The LED you choose should have the appropriate cooling system by way of heat sinks. Making the right choice here will make a big difference in the lifetime of the light.

While HID lamps have a ballast, LEDs have drivers. There are different types of drivers – cheap equipment will have a resistor based driver that can easily break over time due to temperature shifts. Constant current drivers, however, can produce a completely different result – their output is not dependent upon temperature, which means that a constant brightness is achieved regardless of environmental temperature. This is an important consideration I wouldn’t have realized, had I not read this book.

LED Emitters

“Not all LED emitters are created equal,” and is dependent on the manufacturing process. Was emitter quality the manufacturer’s goal, or was it cost savings? Well, you can tell by paying attention to the BIN codes, according to Christopher.

LED Grow Light Designs

Christopher discusses the four different types of LED Grow Light Designs.

Single-Surface LED Grow Lights, LED Light Heads, Clusters/Rosettes, and Tube-Style LED Bars are all thoroughly explained, and the considerations for using each of the different types. Christopher tells you the advantages, disadvantages, and what to look for in each of the different designs. This is an important consideration, and will give you the knowledge you need before you drop the money to buy your own LED lights.

How many LED grow lights do you need?

Another very important consideration. Ultimately, this is dependent on your gardening goals. Christopher explains the considerations, and how you should think about the options that will make the best choices for your garden.

There is much information that fills in between the choice of the light you use and the way you garden. Christopher points out many concepts that you should be familiar with to successfully cultivate cannabis.

It turns out that Christopher’s gardening philosophy lines up very well with the goals of Orion GMP and Hemphacker – here it is in one sentence: “Quality per Harvest/Gardening Zen.” I love this! “Indoor gardening is about the largest quantity of the best quality you can for the least expenditure of resources.” Do yourself a favor and paint that on the wall next to your garden – think about it every time you face a decision, and ask yourself how that decision will affect the end product.

It’s never a good day when you find your webpage hacked. Well, it happened to HempHacker, and it’s been a challenge to get everything back in order. At present, everything is secured.

Fortunately, I’ve been so busy with consulting that I haven’t had time to work on HempHacker content. Unfortunately, my inattentiveness has brought on this hack. “Nothing to do,” as my mentor would say.

That said, I’m working on fixing up the site and bringing everything back to speed.

As usual, if you have any questions, you can reach me at andrew@oriongmp.com.

All the best!


Sometimes it’s best to take a step back, and explain basic concepts of the bigger picture – to take a look at the forest instead of just the trees. Good Manufacturing Practices (GMPs) are complicated systems that assure customer safety. Despite being complicated, you can break them down to a simplified concept of what they are, why they exist, and what it looks like for an operator or technician executing a Standard Operating Procedure (SOP).

What is GMP?

GMP stands for Good Manufacturing Practices. It is also commonly referred to as cGMP, meaning that it is the “current Good Manufacturing Practice” that meets GMP requirements as they are currently regulated. They are the set of regulations that describe all of the operations required to call a drug product, a GMP certified product. Any drug you buy at the pharmacy is produced under GMP conditions.

Why are there GMP regulations?

GMP’s are a way to ensure the public’s safety for manufactured drugs, in order to prevent public health crises. It helps prevent the distribution of adulterated drugs, due to poor manufacturing practices, from reaching consumers that whose health could potentially be harmed.

For example, there was a time before GMPs, where a manufacture could substitute whatever they wanted into their “miracle elixers” that were good for soothing all aches and pains. There was no basis for their efficacy, and the ingredients were completely unregulated. This all changed around 1906 when Upton Sinclair wrote “The Jungle,” where he described the filthy and unsanitary conditions of meat packing plants in Chicago. This completely changed how people thought about how things are manufactured.

What does it mean to operate under Good Manufacturing Practices?

Things have changed since the early 1900’s, and we now have processes in place to make sure that no drug or food substance goes out the door of a factory without having close control over the process. There are many concepts packed into an SOP, and many systems that all work together to make the process work.

So, “from the ground up,” here’s what is looks like when a technician or operator works through a GMP process using their SOP’s. Imagine a technician producing and extract using a Supercritical CO2 process or a Cannabis chef producing an edible with a purified extract.

  1. Obtain the proper and current Standard Operating Procedure (SOP) before starting the job. The SOP will guide the technician through the procedure step-by-step, greatly reducing the chance of operator error.
  2. Thoroughly read through the SOP before starting to make sure that nothing has changed for the procedure, and that the right procedure is being used for the right starting materials.
  3. Follow the instructions exactly, and do not change them or deviate from them.
  4. Work accurately and precisely, paying close attention to the details of each step.
  5. Prevent any contamination or mix-up of materials. Do not have two separate batches of raw materials of in-process materials in the same are without being labeled.
  6. Make sure that no products are mislabeled.
  7. Use equipment that’s been cleaned, calibrated, and is the right tool for the job. All equipment should be well maintained and ready to use. If something is not working, it should be labeled “out of service” until it’s ready for use.
  8. Document your work as it is being done, with initials and dates on the SOP for each step.
  9. Keep your workspace clutter free and clean.
  10. Any documented work may not be destroyed – it can be corrected, but never discard it.
  11. If anything does not go according to the SOP, it must be reported to direct supervisors and the deviation must be documented and analyzed for any risks posed to the end user.

These are the most general guidelines for what GMP looks like in practice. While GMPs are a new concept to the recreational and medical cannabis industry, they’re not new to the pharmaceutical industry. It will take time for the industry to catch up, but it’s not hard to do once a company commits to a culture of quality management systems and cGMPs.

If you have more questions, check out www.oriongmp.com and get a free consultation on putting together your Cannabis related Good Manufacturing Practices and Quality Manufacturing Systems.

The Code of Federal Regulations Title 21, Part 210 is dry reading, but it’s necessary for the cannabis industry to digest. Understanding these regulations, despite their dry nature, is the job of the Quality Assurance unit. In fact, it’s optimal that everyone involved in cGMPs is very aware and familiar with this documentation.

For the sake of this writing, my aim is to inform quality assurance (QA) and quality control (QC) personnel of what they need to know. This is a good place to start. You must understand the following definitions in order to read further into the literature of Good Manufacturing Practices.

Code of Federal Regulations Title 21, Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs

The 21 CFR 210 and 211 only describe the minimum current good manufacturing practices.

The 21 CFR describes the minimum methods, facilities, and controls that need to be in place for manufacturing, processing, packing, and/or holding any drug product. The main goal is to make sure that drugs are manufactured to the specifications they claim to have – it ensures:

  • Safety
  • Identity and strength
  • Quality and purity characteristics

As usual, there’s a consequence for not following the rules, which can be very costly. If it’s found that a company manufacturing under cGMPs is not complying with the 21 CFR, they may:

  • Determine the drug is adulterated
  • Hold the person responsible who was in charge of the process

When your company is found to be violating the 21 CFR, you might get a publicly published 483 warning letter that will say something along the lines of:

“You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.”

Right now, cGMPs for the cannabis industry are in their infancy. When the FDA is regulating the industry, it will be a different story.


When you fully understand these terms, you will have a much easier time understanding the 21 CFR part 211. It’s the baseline of information that sets the stage for everything that’s to come. Take warning though – these are complicated definitions, and often require a background in chemistry or the sciences to fully understand.

Some definitions will be followed by an explanation tying it into terms related to the cannabis industry, as necessary.

Batch – a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

This could be a batch of plants that finished their flowering period at the same time, and were harvested at the same time. Alternatively, it could be the finished extract that was produced by one cycle of a CO2 or hydrocarbon extraction system.

Component – any ingredient intended for use in the manufacture of a drug product, including those that may not appear in the final drug product.

This could be the CO2 or butane used in an extraction.

Drug Producta finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.

This could be flowers that have been fully processed to their dried and cured form, ready for use. It could also be an extract that has been fully purged, packaged, and labeled, ready for use.

Fiber any particulate contaminant with a length at least 3X greater than its width.

Nonfiber releasing filterany filter, which after appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered.

Active ingredient – any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

In the case of cannabis, this would be all the cannabinoids that are present in the final product. Cannabis is tricky in that its final forms are usually a mixture of cannabinoids, and not pure product. All together, the mixture of cannabinoids can be considered the active ingredient.

Inactive ingredient – any component other than an active ingredient.

In the case of cannabis flowers, it would be everything but for the cannabinoids. In the case of an extract, there can be waxes and other lipids that are present with the active ingredient.

In-process material any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product.

In general, there are purification steps involved in producing cannabis products, and relatively few chemical reactions.

Lota batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits.

Similar to a batch, but is the result of a continuous process. Therefore, a lot would be the packaged components from, for example, 100 bottles filled with cannabis tinctures. The tinctures would be filled in a continuous process and all 100 would be filled in a specific identified amount of time or quantity.

Lot number, control number, or batch number any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined.

This is the identifying number of a lot or batch. It’s a locally produced number that’s used to track all activity that was associated with manufacturing a drug substance.

Manufacture, processing, packing, or holding of a drug product includes packaging, labeling operations, testing, and quality control of drug products.

Quality control unit – any person or organizational element designated by the firm to be responsible for the duties relating to quality control.


  1. The concentration of the drug substance (e.g. weight/weight, weight/volume, or the unit dose/volume basis).
  2. The potency, i.e., the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (e.g. expressed in terms of units by reference to a standard).

Theoretical yield the quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production.

Actual yieldthe quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product.

Percentage of theoretical yield – the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage.

Acceptance criteriathe product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units).

Representative sample – a sample that consists of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portrays the material being sampled.


If you have more questions, check out www.oriongmp.com and get a free consultation on putting together your Cannabis related Good Manufacturing Practices and Quality Manufacturing Systems.

It’s always a pleasure when I get an email from someone asking how to break into the industry. I can appreciate the feeling – I was once there. I had hustle, and always worked hard, but I didn’t have a clear vision of the end game.

Ultimately, building yourself up in any industry requires experience. You dig into the work and make a name for yourself. There are many ways to get there, but it’s usually a nonlinear process.

I got my start in the industry in an unlikely place – as a Sergeant in the Marine Corps. I realized during my last tour in Iraq that the cannabis industry was in my future. I had my own personal reasons that drove me towards it, but I saw things lining up. I was honorably discharged in 2006, and I immediately got to work on my education in both cannabis and chemistry.

I hadn’t taken a math class in 5 years, and I had no real background in the sciences. Despite that, I started from the bottom and worked my way through all the liberal arts, math, chemistry, and biology courses. I hustled, and my work paid off with the rewards of leading chemistry study groups – I found that teaching is one of the most rewarding things I can do.

I attended the University of Michigan where I studied Biochemistry and spent my free time learning about the physiology of the endocannabinoid system. I wanted to learn everything about how cannabinoids affect the body and their therapeutic potential. I graduated with my B.S. in 2011 and tasted the accomplishment of my hard work. I planned on going through to a PhD program in Biomedical Sciences, but I first wanted to solid foundation in scientific research before jumping into it.

That’s where some luck comes into play. I landed a job in a biochemistry/genetics laboratory at the University of Michigan where I had the best mentors a young scientist could have. I had all the tools of the trade for HPLC, column chromatography, mass-spec, and a project that needed me to use all of them. I was a protein chemist. Every purification started with extractions, and moved on through multiple steps of column chromatography that ended with HPLC purification.

Andrew - Research day - 2014 poster - Final

I scaled up processes and thought of myself as the Henry Ford of protein purification… Perhaps it was grandiose to think that way. Nonetheless, it’s where I learned to apply the scientific method on a daily basis, and I where I got my basic understanding for extracting and purifying compounds.

I found that a career in academic science was not for me. It is a surprisingly political atmosphere, and I’m not one for bickering. I was accepted into a PhD program, but dropped out just days before the program started. I knew it wasn’t right for me, and, besides, I had an awesome job in the pharmaceutical industry as a Good Manufacturing Practices Quality Control Chemist. It was there, that I realized Good Manufacturing Practices (GMPs) are the future of the cannabis industry – I finally had my clear vision of the end game.

I always kept myself busy moonlighting in the industry while working as a chemist by day. I put the two together, and found that my best bet was to share information and help other people. HempHacker has become my means of teaching people about different aspects of the industry that aren’t fully covered elsewhere.

Since my last job as a GMP QC Chemist, I’ve been doing GMP Consulting for the Cannabis industry. It aligns all my criteria for a job that’s good for me. I’m able to travel, meet new people, help them with their projects, and do a lot of networking in the industry. It’s also very satisfying to know that my work has a positive impact on the quality of products. It’s a very rewarding job for me.

I’m happy with the way it happened, but I know that I would have different advice for someone starting out now. In my next post, I’ll give my suggestions for people getting their start in the industry. I hope it’ll help people get an advanced start.

GMP Cannabis vs. Extraction content on HempHacker

Last week I sent out a survey to subscribers on the HempHacker email list. The goal was to find what content interests readers the most. The numbers and comments speak for themselves. Overall, everyone loves actionable content, but they would also like to see more blog posts about what’s going on at HempHacker.

The people’s choice is extraction content. If the people will have it, it shall be done. However, I am looking for an experienced writer and cannabis alchemist to join the HempHacker team to write for the crowd. My time is being placed mostly on Good Manufacturing Practices (GMP) consulting lately, and I haven’t been able to focus on extraction content.

I received some very helpful constructive criticism, which I greatly appreciate. It helps me understand how I could do my job better. It’s slightly difficult to scale it for all situations since there are different variables for each system, but I understand the need for specific parameters in doing extractions. I will work to improve this.

64% want more extraction content

  • New extraction techniques on the market
    • Wiped film evaporation
    • Short path distillation
  • Specific parameters for supercritical extractions – i.e. useable parameters
    • Amounts to be extracted
    • Solvents used
    • Temperatures
    • Pressures
  • Solventless extractions
  • SFE vs BHO comparisons

36% want more GMP Cannabis related content

  • How to establish GMP systems in your facility
  • GMP Training
  • Good Documentation Practices (GDP)
  • Quality Assurance (QA) and Quality Control (QC) Practices

While I understand the majority want to see more extraction content, GMP consulting pays the bills, and is my primary focus. I really hope that the GMP Cannabis content will also be useful to people doing extractions. It is the definite future of the industry, and I would like to help everyone learn the practices before the FDA regulates the production and processing of cannabis and its extracts.

Thank you to everyone who participated in the survey. Your feedback is very useful to me. As usual, you have an open line of communication to me at andrew@hemphacker.com.


Compliance vs. Good Manufacturing Practices

Just to clarify, there is a difference between Compliance and Good Manufacturing Practices (GMPs). To put it simply, Compliance covers the laws that allow a company to manufacture cannabis and its products, while GMPs provide a framework for how you do it.

Compliance is presently defined as the state by state rules for manufacturing cannabis and cannabis products. It covers the regulations, required transparency, laws, policies, requirements, and standards for manufacturing cannabis. This sets the legal framework for how businesses in their respective states can operate.

Good Manufacturing Practices, on the other hand, are guidelines that come from the Food and Drug Administration and the International Conference on Harmonization. Both provide the requirements for a pharmaceutical manufacturing operation to produce drugs that will be ingested by human beings. They set the operational framework for how to manufacture drugs that are safe for human consumption.

There are also some similarities. Both Compliance and GMPs can have Standard Operating Procedures (SOPs). SOPs are simply the documentation of any process that a company does. They range from simple to complicated. It can be an SOP for sweeping the floors, or an SOP for a 32 step organic chemistry synthesis of tetrahydrocannabinol.

Compliance is without a doubt, the most important first step to establishing your business. Without it, you can face serious legal consequences. Establish your company with a trusted attorney who specializes in compliance, and start manufacturing with peace of mind.

GMPs are the next best step to make your business stand out above the competition – being a GMP Certified facility creates a huge differentiation in your product. With a well defined GMP system in place, you can track improvements to your product over time using the scientific method, ensure consumer safety, and have fully traceable processes. Overall, it’s a win-win adaptation to your business because you improve your processes (and chances to be bought out) and you improve product safety and quality for the consumer (sell more product).

If you have more questions, check out www.oriongmp.com and get a free consultation on putting together your Cannabis related Good Manufacturing Practices and Quality Manufacturing Systems.

Validating SOPs for GMP Cannabis

The objective of validating a procedure is to demonstrate that the procedure is suitable for its intended purpose. This extends to all SOPs. They must be validated to prove that they accomplish their purpose. There are many different processes that can be validated in pharmaceutical operations. Some examples include, but are not limited to, process chemistry, analytical testing, lab facilities, cleaning, equipment, packaging, etc.

For the sake simplicity, this article will cover validation of analytical methods. Method development and validation are all about setting specifications and making sure that the method can reliably achieve those standards. The specifications are discovered during method development, where an analyst works by trial and error to find the right conditions, that are described by example below. It is a tedious process, but once the proper method for analysis is established (i.e. the right column, the right flow rates, the right wavelength, and right temperatures), you have data that should show a reproducible method. From there, it’s a matter of setting the amount of variance that is tolerable to still accomplish the method (i.e. validation parameters).

Analytical method development is the time when the robustness of a method is established. Robust in this sense, means that you can change parameters of the method without seeing variation in the results – that is, despite conditions being less than optimal, you still get good results. Validation checks the variation in methods – you must get the same results for a given method within a specified percentage or relative standard deviation. If a method has been proven to be robust, it has a much greater chance of passing validation (being within the specified variance).

There are three major types of analytical methods: identity tests, assays, and impurity tests. An identity test proves that a certain molecule is present in a sample. An assay shows how much of a molecule is present in a sample. An impurity test shows how much of the sample has degraded or the relative quantities of impurities present in a sample. There are 6 major parameters tested in the validation of analytical methods: accuracy, precision, specificity, detection limits, quantification limits, and range.

Validation parameters require qualified reference standards. Ideally they will be from a third party, manufactured in an ISO environment that ensures the purity. The qualified reference standards are how meaningful comparisons are made to assess each parameter.

  • accuracy – how close to the target value the method reliably achieves
  • precision – how close each measurement is to the other measurements in a series of measurements
  • specificity – identification of the exact molecule that’s being tested – i.e. the method can discriminate between molecules similar to the target molecule.
  • detection limit – the smallest quantity of a molecule that can be detected
  • quantification limit – the smallest quantity of a molecule that can be reliably quantified
  • range – the smallest and largest amount of a molecule that can be reliably quantified in an analytical test

Details of the method should be clearly listed and explained in the validation report. They are important because they clearly lay out the conditions to execute a given method. Here are a few examples of method conditions:

  • Description of the method – e.g. HPLC
  • Type of chromatography column – e.g. C18 Reverse Phase HPLC Column
  • Flow rate and method durations – e.g. 1mL/min – 20 min runtime
  • Detection Wavelength – e.g. 210nm
  • Column Temperature – e.g. 30C

If you have more questions, check out www.oriongmp.com and get a free consultation on putting together your Cannabis related Good Manufacturing Practices and Quality Manufacturing Systems.

Standard Operating Procedures for GMP Cannabis

Standard Operating Procedures (SOPs) are an essential component of Good Manufacturing Practices (GMP). If a process is to be done, it will have an SOP that describes how to do it. SOPs cover topics such as manufacturing, testing, training, management, documentation, lab facilities, cleaning, change control, deviations, and anything else you can think of. It might seem redundant from the outside looking in, but it is a major way for ensuring that pharmaceutical products are produced with consumer safety as the ultimate priority. For the sake of this article, it will mainly focus on manufacturing and testing.

SOPs are meant to be followed exactly as they are written. Improving a manufacturing process is an ongoing goal of GMP. In order to improve a process, procedures must be performed exactly the same way every time the process is performed. The process is treated like an experiment, where all variables are controlled for, as best as possible. Following SOPs is the way of controlling the variables. When a process is repeated, observations of variations will inevitably be made. It’s from observing deviations and variance that changes can be made and  improve the process over time.

Improving the process is important, but the primary reason for following SOPs is to ensure that a quality product is manufactured. Following SOPs to the letter is how this is accomplished. This assumes that the SOPs are well written and specify what a quality product is. With a well written SOP that guides an employee step by step, the chance for mistakes that would compromise the quality of the product are reduced.

As mentioned above, there are many different types of SOPs. While documentation, facilities, etc. are important processes to have SOPs for, processes like manufacturing and testing are most pertinent. This is because manufacturing and testing SOPs have a direct impact on product quality.

For a company adopting GMPs into their process, this is the place to start. In both manufacturing and testing, the SOPs will describe exactly how processes are performed. Every piece of equipment used in the manufacturing process has its own SOP associated with it. It clearly describes how to use the equipment, how to service/qualify the equipment, and describes the equipment maintenance schedule. With the operating procedures for every piece of equipment, the processes that follows are clear.

While SOPs describe how to use the equipment, methods are the documents used to describe the execution of manufacturing and testing. A method is a written document, just like an SOP, that guides the manufacturing and testing, step by step. It is the ultimate guide for the process down to the details of manufacturing a drug substance. As an employee works through the method, they initial and date each step as proof that they completed the step exactly as it is written.

With SOPs and methods describing processes, the amount of variance is reduced. Employees will be performing tasks the same way, day to day, instrument to instrument. Reducing the variance improves the product quality, and reduces the chance for a compromised product. With SOPs and good training, there is a great reduction in opportunities for making mistakes. There are nearly no excuses for mistakes, aside from equipment failure, but that’s another story and another SOP.

If you have any comments or questions, please post them in the comments section or email andrew@hemphacker.com.