Consumers expect that each batch of Dec 13, 2020 · Good Laboratory Practices lay the foundation for ensuring that the standards are attained although the pharmaceutical laboratory practices. In the U. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives. Reagents / media should be accompanied by the certificate of analysis, and the material safety data sheet. Guided Laboratory Tours Aug 3, 2020 · Design criteria for laboratories – General Laboratory Design: Providing a basic level of safety design for the handling of Low-Intermediate toxicity compounds. Course Prerequisites: Graduate Standing PhEn-601 – Principles of Pharmaceutical Engineering PhEn-603 – Pharmaceutical Processing and Manufacturing Permission by the Instructor or the Program Director. The design should also take into account future updates and expansions. Rep. English (EN) (85. ISPE Members receive a discount on Guidance Documents. Next VWR Laboratory-Online-Planning – Free online application. Construction of new facilities and massive renovations to existing facilities have provided a Sep 24, 2001 · I. The goal is to evaluate the process requirements and risks involved with the product and process and build a facility that will for pharmaceutical products and training of technical personnel is collected and reproduced in Volume 1. The concept of quality by design (QbD) was first introduced in 2004 by the US Food and Drug Administration (FDA), as an essential pharmaceutical quality model to be considered in the development of new products and processes (1). , GMP requirements are regulated and enforced by the FDA, which oversees the production and commercialization of all food and pharmaceutical USP 800 Pharmacy Design. H. Good Pharmacovigilance Practices (GVP): These guidelines outline the standards that must be followed when monitoring the safety of pharmaceutical The quality target product profile forms the basis of design for the development of the product. 2. the Management Issues. The compendium, developed for national regulatory authorities, pharmaceutical manufacturers, healthcare professionals, and procurement agencies, is instrumental in Jan 23, 2024 · The National Construction Code (NCC) groups buildings and structures by their use and assigns each type with a classification from “Class 1” to “Class 10”, including some sub-classifications. “The other issue is one of redundancy. 1) This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs May 1, 2024 · 1 May 2024. 7 Terminology for manufacturing areas and HVAC. Oct 5, 2020 · Maintaining pressurization, says Meyer, is one of the biggest challenges that comes with designing or renovating a vivarium lab. These guidelines are applicable to any pharmaceutical quality control laboratory, be it national, commercial or nongovernmental. . Laboratory Design of the laboratory, as well as for an appropriate infrastructure and energy supply. 2 Storage 4 2. , validation of analytical methods, verification of compendial methods, qualification of equipment, validation of computer systems, sampling, review, and approval of test reports. Purpose. and Methodology” and FDA guidelines. Do not work alone in the lab. Such procedures may range from the performance of simple chemical experiments which determine the identity and screening for the presence of particular pharmaceutical Dec 14, 2020 · December 14, 2020. Hence, planning and designing the laboratory is very important to ensure that the needs of the users of the laboratory are met in a layout that provides flexibility to the staff and reduces the probability of accidents or untoward incidents. Biological Defense Research program’s lead facility U. Web. Whenever possible, pharmaceutical grade substances must be used for compounds selected for medical treatment or to prevent or The SAGER guidelines for reporting sex and gender information in methodology or study design, data analysis, results, and interpretation of findings are strongly encouraged. USP 800 Entry. 77 KB - PDF) 1. Quality by design (QbD) is defined as “the construction of quality throughout the product life cycle, beginning with the development stage” or “designing and developing the product and relevant production processes to be used throughout product development so that the product consistently delivers predetermined quality at the end of the production process. Other WHO guides to Jan 1, 2024 · 10. Also, the COVID-19 pandemic has made clear that risk management, crisis management and European Medicines Agency-Food and Drug Administration pilot programme for parallel assessment of quality-by-design applications: lessons learnt and questions and answers resulting from the first parallel assessment. N ovartis Vaccines (Novartis) has ap-plied a structured implementation of lean principles across Quality Control (QC) laboratories in Basic Architectural Design Considerations for a Laboratory Published in: Pharma Ally, Feb 16-28, 2010 The Ministry of Health & Family Welfare, under the Drugs & Cosmetics Act, has laid down “Good Laboratory Practices” requirements and made the compliance of GLP mandatory from 1st November 2010, for all pharma companies. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years. Regulatory Compliance. 3. 2 m/sec. ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. It provides a step-by-step process that guides the reader through all phases of producing a Jun 5, 2023 · The Stanford Laboratory Standard & Design Guide is a resource document for use by faculty, staff, and design professionals during the planning and early design phases of a project. Method transfer may involve comparative testing, co-validation between two sites (Lab-to-Lab), complete or partial revalidation and comprehensive documen-tation (Transfer Plan, Protocol, Report). Quality by design. Part 1 Planning and Operational Aspects. “Trying to keep cognizant on maintaining pressurization in rooms and not have odors leak out,” he says, is a common concern. By making sure that the staff, equipment, environment, reagents and media and referencing are well instituted, this will collectively result in good laboratory practices. Feb 2, 2021 · Best Practices for Designing and Building a Pharmaceutical Manufacturing Facility. Modern QC Microbiology Laboratory Design and Layout Considerations. Technical Issues in a Microbiology Laboratory that Influence. Important to understand the manufacturing processes and conduct the facility programming. 1. Design Of Modern Pharmaceutical Facilities (OSD) - Longdom Mar 7, 2020 · Laboratory Design and Planning Guide for 2021. For example, high and low temperature alarms can warn users as to when the temperature is deviating. If in vivo biological testing (e. rabbit pyrogen test) is included in the scope of the laboratory activities then the animal houses should be isolated from the other laboratory areas with a May 16, 2017 · Research Laboratories are workplaces for the conduct of scientific research. These guidelines are not meant to be used in lieu of regulatory and code reviews. Design approach for constructing a sterility testing laboratory Dec 29, 2023 · The pharmaceutical or drug quality-related regulations appear in several parts of Title 21, including sections in parts 1-99, 200-299, 300-499, 600-799, and 800-1299. At Merck, we're following the science to tackle some of the world's greatest health threats. In the pharmaceutical and medical device industry, the microbiology laboratory is often a spin-off of the analytical chemistry 1. Participants also address issues with new laboratory construction, renovation, and decommissioning. To achieve delivery of a facility that how laboratory design impacts the health and safety of lab users and their surroundings. functions. Operational access. Harvard faculty and leading experts will discuss general laboratory design challenges and issues that Jun 1, 2024 · Therefore, according to the needs of laboratory tests, we can design a pharmaceutical microbiology laboratory layout with reference to WHO guidelines (Laboratory Design and Maintenance, 2020). Date: 21st August 2019 (Rev 01) AS/NZS 2982. Laboratory Design and Construction. Later, QbD was supported by the International "Good Laboratory Practice GLPMA Expectations When Using a Contract Quality Assurance Service", reviewed January 2015 Guidance on the use of GLP Study Report Amendments (april 2015) Guidance on test types stated on GLP compliance statements, reviewed January 2015 Clinical trials help find new treatments to help save and improve lives. Jul 29, 2018 · Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline. C. The pharmaceutical industry is governed by a complex web of regulations and guidelines aimed at safeguarding public health. The overall impact of regulations on a pharmaceutical laboratory can be best illustrated by looking at the whole sample/data workflow (Figure 1). USP 800 design requirements prioritize staff safety. Many labs manufacture and create products and pharmaceuticals that require specific environmental conditions during production. 4 Cross contamination and potent product issues. May 25, 2024 · Creating collaborative pharmaceutical laboratory spaces requires a methodical approach that harmonizes inventive design with pragmatic implementation. Considerations for the quality target product profile could include: Intended use in clinical setting, route of administration, dosage form, delivery systems; Dosage strength(s); Container closure system; See glossary. Once a method is validated, it may require transfer. We have aided in the designing and building of countless laboratory projects nationwide, creating safe, high-tech environments for researchers to perform groundbreaking research in the worlds of pharmaceuticals, cannabis testing, diagnostic research, pathology, forensics, and more. U. 10 June 2015. As we step into 2024, a new era of advancements beckons, influencing the way laboratories are conceived and organized. on WHO guidelines for medicines quality assurance, quality control (QC) laboratories and transfer of technology on 27–31 July 2009, the need was identified to incorporate a new section on “Product quality review” under Chapter 1: “Quality assurance”. 8 Barrier-isolator technology. Sign-up for the free email updates for your daily dose of pharmaceutical tips. The term “quality control” refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical. Additional features can help pharmaceutical labs feel safe when using a stability chamber. Leave a Reply Cancel reply. 5 Facilities and systems 7 2. Airlocks, PAL/MAL, and pass-throughs. Guidance for Industry. Implications of COVID-19 on laboratory design will also be discussed. Never leave an ongoing experiment unattended. ” 1. 1 Laboratory design features 1 1. Learn more about our Plant Layout Design Services. com, a widely-read pharmaceutical blog since 2008. Location: N JIT, N ew ark, N J, K upfrian H all , Room 110. It gives engineers, owners, and system operators the design and control strategies they need to reduce the laboratory's energy footprint while ensuring laboratory, e. Jul 29, 2016 · Pharmaceutical CGMPS for the 21st Century — A Risk-Based Approach: Second Progress Report and Implementation Plan. Samples come in via a drop-off station at one end of the building and flow through the testing process toward the other end where waste disposal is managed. LIST OF RELEVANT STANDARDS FOR LABORATORY DESIGN. Design: Pharmaceutical plants should be designed using best practices in order to minimize risks and ensure safe and effective production. In the dynamic landscape of scientific research, laboratory design and planning play pivotal roles in fostering innovation, efficiency, and safety. Authors of review articles are advised to address the methods used for selecting, locating, extracting, and synthesizing data; systematic reviews are required to do so. They do not replace national legislation for protection of the environment and personnel. FDA and other agencies have held inspections of QC This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick. In order to ensure that a potentially hazardous environment within the Laboratory does not affect areas outside the designated laboratory, a negative differential air pressure relative to the surrounding areas is recommended. With this knowledge, you can greatly increase health and safety in the labs you design or manage while promoting the quality of the laboratory environment. Lab design specialists for over 40 years. wiley. 3. The class of building is a measure of the building’s likely use, fire hazard potential and occupants, so facility design is developed in May 28, 2024 · Pharmaceutical companies are an important part of the medical field. The document, titled ISPE Good Practice Guide: Quality Laboratory Facilities, defines design guidelines for quality laboratories supporting GxP-regulated facilities producing pharmaceutical products for human and animal The European Medicines Agency's scientific guidelines on specifications, analytical procedures and analytical validation help medicine developers prepare marketing authorisation applications for human medicines. In addition, several updates were suggested to further enhance the guidelines. 1 Facility space 3 2. AS/NZS 2243. 2 Critical process steps. EHS must be included early on in all laboratory design projects. equipment and personnel, if applicable, present and performing their normal work. S. Never lift any glassware, solutions, or other types of apparatus above eye level. For a complete list of scientific guidelines currently open for consultation, see Public consultations. ” ICH. 6 Laboratory equipment 9 SECTION 3 Design considerations - heightened control measures 11 Oct 11, 2018 · In pharmaceutical laboratories, GLP should be followed. 2 . Dec 9, 2021 · Bioprocess Facility Design — Layout Rules And Configurations. Course Description Apr 10, 2020 · Stability chambers used for stability testing in the pharmaceutical industry must be durable and their long-term performance should be rigorously tested. Means and procedures should be in place (in case of possible supply problems) to ensure that the laboratory can continue its activities. 3 Surfaces and finishes 5 2. 9 Other considerations. Laura-Ann Chin has more than 12 years of international and domestic contract and hands-on process engineering experience in the design and construction of current GMP facilities in the US, Europe, and Asia. It offers vital information on topics including requirements for source bulk waters, control of biofilms, and the three Feb 29, 2024 · The 10th edition of the Quality assurance of pharmaceuticals: a compendium of guidelines and related materials is an essential resource for the global healthcare community, designed to strengthen pharmaceutical standards worldwide. The laboratory should be located designed, customized and maintained to suit the performance of all Q. Oct 1, 2018 · Quality control guidelines. In this comprehensive guide, we will explore the latest trends and innovations shaping laboratory design plans and layouts. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical Incorporating Lean Principles into Pharma QC Lab Design - Article. A cleanroom (facility) in normal operation, with all services functioning and with. For drug sponsors that are considering building their own manufacturing facilities, an expert project team is crucial. Temperature range of 20 – 22°C. Jun 23, 2016 · The key to layout of a biopharmaceutical facility is solving the mixed-integer programming problem of multiple goals, constraints, and adjacencies — and all for the lowest cost (typically, the lowest square footage). Equipment: The type and size of equipment used in a pharmaceutical plant should be based on the products being produced. Amicus Labline are Australiaʼs leading lab design and fitout specialists, with extensive experience in planning, designing and building laboratories for the resources, energy, pharmaceutical, biotechnology, healthcare, R&D and education sectors. Whether SGS’ Life Science Services is the The European Medicines Agency's scientific guidelines on the quality of human medicines help applicants prepare marketing authorisation applications. Close Lean design by three major design-architect companies, Lean design recommendations and guidelines for achieving the Lean vision and workshop feedback. 22 – 26°C (Tropical countries) Relative humidity 50-60 % (comfortable conditions) For comfortable working conditions air velocity should not exceed 0. Contact us today to get your pharmaceutical plant designed! Call or Whatsapp us at 9996859227 or write to us at contact@pharmadocx. The principle of ethical behavior. Good manufacturing practice ( GMP) is a quality assurance system and set of guidelines used by manufacturing laboratories to ensure the purity and quality of their products. enilediugamrahp@ofni :liamE Need Help: Ask Question 8. 14. PhEn-602 Pharmaceutical Facility Design. A large number of quality control related 483s and warning letters in recent years demonstrate that regulated companies are having problems with the implementation of regulations for quality control laboratories. Produced by pharmaceutical manufacturing industry professionals, ISPE Guidance Documents provide the practical, "real world" information you need to stay current with industry best practices and regulatory expectations. Pharmaceutical Technology, Pharmaceutical Technology-02-01-2021, Volume 2021 Supplement, Issue 1. 102) 6:00 – 9:05 p. test and analysis required. 2 Risk assessment and needs assessment 1 SECTION 2 Design considerations - core requirements 3 2. This course provides a unique opportunity for architects, EHS professionals, engineers, lab users, and lab managers to collaborate on laboratory design. Selection of methods to be used for microbiological. Jennifer Swedell Jennifer (AIA, LEED AP BD+C) is a member of NOMA, an associate principal with CO Architects, and a seasoned laboratory planner and designer with over 17 years of lab design experience for Feb 27, 2024 · In the era of evidence-based medicine, clinical laboratories constitute one of the vital spaces of a hospital or healthcare in general. 6 Integrated facility design. See full list on onlinelibrary. As such, we can examine the dimensions of workflow in a modern microbiology laboratory moving from general to specific. If you are the last person to leave the lab, make sure to lock all the doors and turn off all ignition sources. Facility layout must be an integrated design satisfies the following: Process requirements. 3 as follows:1 a) as a margin for particle concentration limit alert levels, for example, ISO 7 class limit, C class, is 352,000 particles/m 3 for particles ≥ 0. Because compounding pharmacists handle hazardous drugs in USP 800 labs, the room is designed to contain and remove chemical contamination. “Quality Guidelines. 2. Following are the main points those should be considered under GLP. The guidelines are applicable to existing legacy laboratories (traditional and open space design), renovation of existing laboratories and design of Greenfield laboratory locations. We provide both architectural and building services Sep 24, 2012 · The International Society for Pharmaceutical Engineering (ISPE) announced the publication of a new guidance document on the design of pharmaceutical quality laboratories. Input air systems need dust filtered with coarse particles G4 pre-filter. The authors recognize that in the 21st century clients are pushing project design teams to 6 days ago · Editor’s note: Items 1–5 in the “Pipe and tank design” section of this article have been reprinted from Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control, by Tim Sandle, Chapter 10: Assessment of Pharmaceutical Water Systems,” page 120 (2015), with permission from Elsevier. The pharmaceutical industry has been in existence for several years now and is considered to be a key industry in the medical field. Oct 1, 2016 · A focus on QbD benefits for the pharmaceutical industry is provided. com The ISPE Good Practice Guide: Quality Laboratory Facilities is a comprehensive guide to defining design guidelines for Quality Laboratories supporting GxP-regulated facilities that produce pharmaceutical products for human and animal applications. In this case, Geisinger wanted its three main types of clinical The guideline continues to provide a general framework for the principles of analytical procedure validation applicable to products mostly in the scope of Q6A and Q6B. Q14 Analytical Procedure Development Guideline Mar 29, 2019 · “Labs are quite complex and diverse, so there are many ways to design what would be called a sustainable lab,” says Louis DiBerandinis, MS, CIH, CSP, Program Co-Director of Guidelines for Laboratory Design, Instructor in Industrial Hygiene at the Harvard T. As a laboratory construction firm, we are experts in creating custom lab furniture and layouts for the pharmaceutical industry. The ISPE Good Practice Guide: Quality Laboratory Facilities is a comprehensive guide to defining design guidelines for Quality Laboratories supporting GxP-regulated facilities that produce pharmaceutical products for human and animal applications. During the inspections carried out when prequalifying laboratories, the inspectors had noticed that some of the texts of these guidelines might benefi t cGMP and GLP Regulations and Inspections for Quality Control Labs - An overview. The proposed revised guidelines for Good Clinical Laboratory Practices (GCLP), 2021 aim to establish minimum criteria which should be followed by clinical and research laboratories involved in examining human samples, in routine healthcare delivery and clinical research, respectively, in addition to internationally accepted guidelines. Guidelines for the Use of Non-Pharmaceutical Grade Compounds in Laboratory Animals. WHO definition of Active Pharmaceutical Ingredient: “A substance used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological Safety Guidelines. The WHO Expert Committee on Specifi cations for Pharmaceutical Preparations adopted in 2009 a revised version of the Good practices for pharmaceutical quality control laboratories (1). Objective (1. Reference Schedule of Current Australian Standards for Laboratory Design. (Sect. Guidance to Reduce Your Lab's Energy Footprint. Most animal facilities have a certain level of Feb 16, 2024 · The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulations for human pharmaceuticals. These guidelines relate to all microbiology laboratories involved in sterility Testing; detection, isolation, enumeration and identification of microorganisms and assay activities, whether they are independent or a department or unit of a pharmaceutical manufacturing facility. Novartis Vaccines has applied a structured implementation of lean Sep 27, 2023 · The draft now published states: "Since the last revision of the guidelines, the experience from inspections of pharmaceutical quality control laboratories has enabled WHO to identify sections requiring clarification and the necessity to add new sections. m . Process Validation: General Principles and Practices. 1. Labs not only monitor and control the quality of incoming APIs (active pharmaceutical ingredients), and other supplies used in the manufacturing process; QC Labs are also instrumental in the batch release The principle of scanning the external environment. 4 Furniture 7 2. All reagents, media and chemicals, including solvents and materials used in tests and assays, should be of appropriate quality. They play a significant role for everyone involved, such as the producer, the doctor who prescribes and the consumer who is the patient. Food and Drug Administration. In pharmaceutical GMP cleanrooms, specific attention must be put to Personnel Air Locks (PAL) and Material Air Locks (MAL) entry and exit. 3 Protection of the product. This laboratory design includes a three-zone corridor separation system, a buffer zone, a positive and negative pressure Oct 27, 2023 · This blog explores the key elements that go into designing a pharmaceutical manufacturing facility, highlighting the critical factors that contribute to its success. 5 μm, but, for process reasons, its alert level, C lim, can be chosen as 100,000 particles/m 3 Jun 1, 2024 · The main objective of this article is to provide concise literature on how to design a modern pharmaceutical microbiology laboratory with all recommended safety features by various pharmaceutical regulatory guidelines. It provides a step-by-step process that guides the reader through all phases of producing a You will have to think about including alarms and microbiological monitoring devices in your GMP facility & cleanroom design. INTRODUCTION (1) A. 297). This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design. She specializes in single-use solutions and modular technologies for scale-up, scale-out, and technology transfer in maximizing This includes an understanding of intra-laboratory relationships, block planning, and schematic design toward a common goal of efficiency and economy. Our progress is due in large part to the important and tough scientific questions we set out to answer with our trials and collaborations. The principle of open communication with supervisors, peers, and employees. May 23, 2014 · This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. 2243 SAFETY IN LABORATORY. In the areas between, rooms are dedicated to chemical weighing, glass washing, sample incubation, and CTU storage. The purpose of this Pharmaceutical Microbiology Manual (PMM) is to collectively clarify, standardize, and communicate useful analytical procedures that are not specifically addressed Feb 7, 2024 · All opinions expressed in Lab Planning 101 with Jennifer Swedell are exclusive to the author and are not reflective of Lab Design News. 1 These guidelines set out good practices applicable to facilities handling pharmaceutical products (including active pharmaceutical ingredients (APIs)) that contain hazardous substances such as certain hormones, steroids or cytotoxins. Validation studies Sep 16, 2014 · The quality control (QC) laboratory plays a critical role in pharmaceutical production, for both in-process and finished product testing. To contain harsh drugs and contaminants in the lab, the USP 800 door swings into the room. These guidelines (Q2(R2) and Q14) are intended to complement ICH Q8 to Q12 Guidelines, as well as ICH Q13 for Continuous Manufacturing. Never purposefully smell or taste chemicals. This second edition of ASHRAE Laboratory Design Guide is a comprehensive reference manual for the planning, design, and operation of laboratories. Reference Number: EMA/430501/2013. com. Get a glimpse of how we work to improve A joint venture of HDR and WSP USA provided architectural and engineering design services for a new replacement facility for the U. Cleanroom design goes beyond simply creating a controlled environment for conducting lab work. Now Hiring: Are you ready to take on some of the best challenges the industry has to offer? The guidelines cover a wide range of areas, including the design and operation of laboratories, the training and qualifications of laboratory staff, and the management of quality control systems. The impact of COVID-19 vaccines and rapid expansion of new therapies facilitated by cell and gene technology has changed some of the landscape for facility design over the past few years. March 7, 2020. [1] 8. Air Handling Specifications. Personnel flows. Due to the uncertainty of the data at the design stage, the standard suggests adopting a compensation factor, expressed in paragraph 6. Our firm was responsible for planning and architecture for the High Containment Laboratories (BSL4, and the BSL3E Imaging Oct 27, 2023 · From regulatory compliance to environmental impact, every decision can have far-reaching implications. Equipment. 5 Aseptic processing area. It is important to review laboratory design with the proposed occupants as early in the process as possible, to ensure compatibility with anticipated research or teaching activities. Chan School of Public Health, and Director of Environment, Health, and Safety at 2 METTLER TOLEO Compliance by Design This guide is designed to provide a valuable and convenient information resource to aid in the design of pharma water systems that are compliant with the requirements of global pharmacopeias. g. . 1 Product and process requirements. This Guide is to be used in conjunction with Stanford’s Facilities Design Guidelines and applies to construction projects for all Stanford University facilities Jul 6, 2017 · The laboratory design facilitates sample flow. Material flows (product, movements) Equipment layout. moc. MIPL, acting as turnkey interior contractors May 31, 2018 · Prev Pharmaceutical Control Lab – layout. Volume 2, first published by WHO in 1999, repro-duces guidelines related to good manufacturing practices (GMP) and to the inspection of pharmaceutical manufacturers and drug distribution channels. This WBDG Building Type page will summarize the key architectural, engineering, operational, safety, and sustainability considerations for the design of Research Laboratories. In the preparation of reagent solutions / media in the laboratory: C ourse D ay and Tim e: W ed. Jul 30, 2020 · For further guidance see the draft working document WHO guideline on good practices for pharmaceutical microbiology laboratories (reference QAS/09. Investigators are expected by regulatory authorities to use pharmaceutical-grade compounds (PGC) in animals when they are available. ev gl bz eo ry oc vl kj xd ts