QUALITY MANAGEMENT SYSTEM REQUIREMENTS FOR …

Working document QAS/19.811/Rev.1

July 2019

Draft for comments

1

QUALITY MANAGEMENT SYSTEM 2

REQUIREMENTS FOR NATIONAL INSPECTORATES 3

(July 2019) 4

DRAFT FOR COMMENTS 5

6

7 © World Health Organization 2019 8 9 All rights reserved. 10 11 This draft is intended for a restricted audience only, i.e. the individuals and organizations having received this draft. The draft 12 may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any 13 form or by any means outside these individuals and organizations (including the organizations' concerned staff and member 14 organizations) without the permission of the World Health Organization. The draft should not be displayed on any website. 15 16 Please send any request for permission to: 17 18 Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies Standards and Norms, Department of Essential 19 Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland, email: [email protected]. 20 21 The designations employed and the presentation of the material in this draft do not imply the expression of any opinion 22 whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or 23 of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate 24 border lines for which there may not yet be full agreement. 25 26 The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or 27 recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and 28 omissions excepted, the names of proprietary products are distinguished by initial capital letters. 29 30 All reasonable precautions have been taken by the World Health Organization to verify the information contained in this draft. 31 32 However, the printed material is being distributed without warranty of any kind, either expressed or implied. The responsibility 33 for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for 34 damages arising from its use. 35 36 This draft does not necessarily represent the decisions or the stated policy of the World Health Organization. 37

38

Please send any comments you may have to Dr Valeria Gigante ([email protected]), Technical Officer,

Medicines Quality Assurance, with a copy to Ms Claire Vogel ([email protected]) by 20 September 2019.

Working documents are sent out electronically and they will also be placed on the WHO Medicines website

(http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/) for comments under

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SCHEDULE FOR DRAFT WORKING DOCUMENT QAS/19.811: 39

QUALITY MANAGEMENT SYSTEM REQUIREMENTS 40

FOR NATIONAL INSPECTORATES 41

Description of Activity Date

During the Joint Meeting on Regulatory Guidance for

Multisource Products, several WHO guidances were

identified for updating, including the Quality Management

System for National Good Manufacturing Practise

Inspectorates (WHO Technical Report Series (TRS), No.

902, Annex 8, 2002).

Copenhagen, July 2016

The Fiftieth World Health Organization (WHO) Expert

Committee on Specifications for Pharmaceutical Preparations

(ECSPP) confirmed the need to update the guidances that had

been selected for review during the Joint Meeting on

Regulatory Guidance for Multisource Products (Copenhagen,

July 2016) including the Quality System Requirements for

National Good Manufacturing Practices Inspectorates.

17 - 21 October 2016

Preparation of an in-depth situation analysis with regard to

the need for updating the guidance texts identified in the

before-mentioned meetings.

October 2017 – June 2018

During the consultation on Good Practices for Health

Products Manufacture and Inspection, the WHO Secretariat

presented the detailed analysis conducted on the cluster of

guidelines proposed for revision.

10-12 July 2018

The Fifty-third ECSPP recommended the WHO Secretariat

revise the Guideline Quality Management System for

22-26 October 2018


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National Inspectorates according to the proposals made by

the WHO Secretariat.

Preparation of the first draft working document by Dr

Dimitrios Catsoulacos from the WHO Prequalification (PQ) -

Team Inspection.

February - May 2019

Circulation of the draft document to WHO (PQ) - Team

Inspection for comments.

May 2019

Mailing of working document inviting comments, including

to the Expert Advisory Panel on the International

Pharmacopoeia and Pharmaceutical Preparations (EAP),

and posting of the working document on the WHO website

for public consultation.

May – 23 June 2019

Consolidation of comments received and review of feedback.

Preparation of working document for discussion.

End of June 2019

Discussion of working document and feedback received

during the public consultation in the informal Consultation on

Good Practices for Health Products Manufacture and

Inspection.

2 -5 July 2019

Revision of the working document based on comments

received during the informal Consultation on Good Practices

for Health Products Manufacture and Inspection.

July 2019

Mailing of the revised working document for second round

inviting comments, including to the EAP, and posting the

working document on the WHO website for public

consultation.

Mid-July – September

2019


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42

43

Consolidation of comments received and review of feedback.

Preparation of working document for discussion by the

ECSPP.

End of September 2019

Presentation to the Fifty-fourth meeting of the ECSPP. 14 -18 October 2019

Any other follow-up action as required.


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QUALITY MANAGEMENT SYSTEM REQUIREMENTS 44

FOR NATIONAL INSPECTORATES 45

46

BACKGROUND 47

48

During the Joint Meeting on Regulatory Guidance for Multisource Products (Copenhagen, July 49

2016), several World Health Organization (WHO) guidances were identified for update. In 50

October 2016, the Fiftieth WHO Expert Committee on Specifications for Pharmaceutical 51

Preparations (ECSPP) confirmed the need to update the selected guidances. 52

53

Following up on the recommendation from the Fiftieth ECSPP, the WHO Secretariat conducted 54

a detailed analysis of the cluster of guidelines proposed for revision. The outcome of this 55

analysis was discussed during the consultation on Good Practices for Health Products 56

Manufacture and Inspection (Geneva, July 2018). In particular, considering that the WHO 57

Quality System Requirements for National GMP Inspectorates (1) defines the basic 58

requirements applicable to quality systems for the operation of inspection services within 59

national regulatory authorities (NRA) concerned with GMP inspections, the WHO Secretariat 60

proposed a strategy for revision that includes aligning the guidance with ISO 9001:2015 61

principles (2) and with Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) 62

relevant guidance (3), as well as broadening its scope to include all GXP-related inspections 63

conducted by a NRA. 64

65

The Fifty-second ECSPP endorsed the proposal for revision and recommended the WHO 66

Secretariat to revise the WHO Quality System Requirements for National GMP Inspectorates 67

aligning its content to international standards, the latest quality management systems (QMS) 68

principles and to expanding the scope. 69

70

1. Introduction 71

2. Scope 72

3. Glossary 73

4. Quality management system 74

5. Context of the inspectorate 75


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6. Management and leadership 76

7. Management system planning 77

8. Resources 78

9. Documentation 79

10. Operational planning and performance evaluation 80

11. Publications 81

82

References 83

Further reading 84

85

86


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1. INTRODUCTION 87

88

1.1 This document describes the quality management system (QMS) requirements 89

for the operation of inspection services within national regulatory authorities 90

(NRA) or other state structures (for the purpose of this guidance, the term 91

“NRA” will be used in the text to represent both NRA and other state 92

structures). It is intended that each inspection service uses these requirements 93

as the basis for developing and implementing its own QMS. Where the 94

inspectorate operates under the umbrella of the NRA QMS, consideration 95

should be given to the WHO Guideline on the Implementation of Quality 96

Management Systems for National Regulatory Authorities (4). 97

98

1.2 The adoption of a common standard for QMS requirements is an essential 99

element in achieving consistency in inspection practices and facilitating 100

structured communication with other units of the NRA, as well as enabling 101

mutual confidence and permitting recognition between pharmaceutical 102

inspectorates. 103

104

2. SCOPE 105

106

This document outlines the QMS requirements for pharmaceutical inspectorates, competent 107

for the oversight of GXP operations. 108

109

3. GLOSSARY 110

111

corrective actions 112

Steps taken to eliminate the cause of existing nonconformities in order to prevent recurrence. 113

The corrective action process tries to make sure that existing nonconformities and potentially 114

undesirable situations do not happen again. 115

116

117

118


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good practices (GXP) 119

Acronym for the group of good practice guides governing the preclinical, clinical, 120

manufacturing, testing, storage, distribution and post-market activities for regulated 121

pharmaceuticals, biologicals and medical devices, such as good laboratory practices (GLP), 122

good clinical practices (GCP), good manufacturing practices (GMP), good pharmacovigilance 123

practices (GPP) and good distribution practices (GDP). 124

125

internal audit 126

An examination and assessment of all or part of a quality system with the specific purpose of 127

improving it. An internal audit is usually conducted by an independent (of the function to be 128

audited) and qualified team of experts designated by the management for this purpose. 129

130

quality indicators 131

Selected data intended to be monitored and used in assessing trends in performance. 132

133

quality management system 134

An appropriate infrastructure, encompassing the organizational structure, procedures, 135

processes and resources necessary to ensure adequate confidence that a product (or service) 136

will satisfy given requirements for quality. 137

138

quality manual 139

A document that includes the quality policy and objectives and describes the various elements 140

of the QMS. 141

142

quality policy 143

A brief statement that describes the organization’s purpose, overall intentions and strategic 144

direction, provides a framework for quality objectives and includes a commitment to meet 145

applicable requirements. 146

147

148

149

150


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rapid alert 151

An urgent notification submitted by a NRA participating in the Rapid Alert System concerning 152

measures taken against a product placed on the market which poses a risk to consumers’ health 153

and/or safety. 154

155

risk management 156

The systematic application of quality management policies, procedures and practices to the 157

tasks of assessing, controlling, communicating and reviewing risk. 158

159

standard operating procedure (SOP) 160

An authorized written procedure giving detailed instructions for performing a task or following 161

a process in accordance with legislation, official guidance or internal standards. 162

163

4. QUALITY MANAGEMENT SYSTEM 164

165

4.1 QMS is a wide-ranging concept which covers all matters that are necessary to 166

implement the inspectorate’s quality policy and to meet predefined objectives. 167

168

4.2 The QMS should define the inspectorate’s scope and context within the regulatory 169

mandate as well as cover all functions, processes and activities 170

171

4.3 The primary aim of an inspectorate’s QMS is as follows: 172

173

a. to ensure its ability to consistently provide services that meet the organization’s 174

objectives, as well as legal requirements and interested parties’ expectations; and 175

176

b. to facilitate continual improvement and provide a sound basis for sustainable 177

development in compliance with statutory and regulatory requirements. 178

179

4.4 The QMS should at least describe and manage organizational structure, responsibilities, 180

procedures, systems, processes and resources required, to provide value and achieve 181

results for the inspectorate and relevant interested parties. 182


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4.5 Typically, the legal basis for the establishment of the inspectorate, its mandate, the 183

quality policy and the principles of the QMS should be documented in a quality manual 184

or equivalent document. 185

186

4.6 The QMS should enable senior (“top”) management to best use available resources and 187

systems in order to achieve the inspectorate’s targets and quality objectives. Senior 188

management’s commitment and active participation is essential to ensure 189

implementation of the QMS and to support of staff within the inspectorate. 190

191

5. CONTEXT OF THE INSPECTORATE 192

193

5.1 The legal basis for the establishment of the inspectorate, its mandate, as well as statutory 194

and regulatory responsibilities and functions, should be clearly defined. 195

196

5.2 The inspectorate should determine its scope and its strategic direction in order to 197

achieve the intended objectives. 198

199

5.3 The structure and operation of the inspectorate should be such that impartiality 200

is safeguarded. Rules for deontology, confidentiality, ethics and conflict of 201

interest should be clearly defined and obeyed. Where relevant, the inspectorate 202

should implement a policy which distinguishes between the process of 203

inspection and that of providing an advisory service. This service should be of 204

benefit to all of industry and not solely to individual organizations. 205

206

5.4 The relationship of the inspectorate with other departments within the same NRA and 207

other agencies and organizations outside the inspectorate, as well as any other 208

stakeholders, should be described and documented where relevant. 209

210

MANAGEMENT AND LEADERSHIP 211

212

6.1 Senior management should make a formal commitment to the implementation of a 213

documented quality policy that is compatible with statutory requirements and relevant 214


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objectives. 215

216

6.2 Senior management should ensure that inspectorate’s services and functions are aligned 217

with regulatory requirements and NRA’s objectives, as well as meeting interested 218

parties’ expectations. 219

220

6.3 Senior management is accountable for the integration of QMS requirements into the 221

inspectorate’s processes and functions, for communicating the importance of QMS 222

principles and for the overall effectiveness of the QMS. In addition, senior management 223

should promote the application of risk management principles and support the 224

engagement and contribution of personnel in improving the QMS. 225

226

6.4 Senior management should ensure that the pharmaceutical inspectorate has sufficient 227

and appropriate resources at all levels to enable it to meet its objectives. 228

Responsibilities, authorities and reporting structure for relevant roles should be clearly 229

defined and documented in the QMS. The structure should be defined in organization 230

charts. 231

232

6.5 An appropriately experienced and qualified person should be nominated as a 233

QMS responsible person. This person should have direct access to senior 234

management. If necessary, this task may be assigned to more than one person. 235

236

6.6 There shall be a system for periodic management review of the QMS effectiveness, 237

including process improvements. Such reviews should be documented and records 238

should be maintained for a defined period. 239

240

7. MANAGEMENT SYSTEM PLANNING 241

242

7.1 The inspectorate should establish appropriate objectives for the intended level of 243

service and of its functions that should be consistent with the quality policy and 244

regulatory requirements. Risk management and sustainable development principles 245

should be considered for the establishment of these objectives. 246


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7.2 These objectives should be communicated to personnel at all levels and be updated 247

whenever necessary. 248

249

7.3 Appropriate resources should be available to meet these objectives. Roles and 250

responsibilities should be defined and, where appropriate, timelines for completion 251

should be established. Systems for monitoring and evaluating results should be 252

established. The inspectorate should maintain all necessary information on quality 253

objectives. 254

255

7.4 The inspectorate should establish a documented change management system that should 256

ensure that change requests are assessed, approved or rejected, that appropriate 257

resources are allocated, and that roles and responsibilities are defined. Any change 258

should be documented, communicated to the personnel and evaluated after 259

implementation to ensure the objectives are met. The change management system 260

should ensure that continual improvement is undertaken in a timely and effective 261

manner. 262

263

8. RESOURCES 264

265

8.1 The inspectorate should have an organizational structure, required resources 266

(financial, human, facilities and others) and documented procedures that enable 267

it to meet its objectives, to perform inspection activities in accordance with 268

official GXP guidelines and national legislation and carry out its functions and 269

operations satisfactorily. Where necessary, measures and resources for the 270

safety of personnel should be available. 271

272

Personnel 273

274

8.2 The inspectorate should employ the required personnel possessing the 275

appropriate expertise to perform its functions, including inspections, and to 276

determine whether the inspected entities comply with the principles of current 277

GXP guidelines and with relevant legislation. 278


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8.3 Personnel responsible for inspections should have appropriate qualifications, 279

training, experience and knowledge of the inspection process and subject and 280

should be periodically evaluated. They should have the ability to make 281

professional judgements as to the conformity of the inspected party with the 282

requirements of good practices and the relevant legislation, and be able to apply 283

risk management principles in their decision-making process. 284

285

8.4 The inspectorate should ensure that induction and continuous training is provided to 286

inspection personnel on administrative, regulatory and technical topics to maintain 287

the inspectors’ competency aligned with current industry practice, technological 288

advancements and regulatory changes. Training should be documented and its 289

effectiveness assessed periodically. 290

291

8.5 The inspectorate should maintain documented and up-to-date information on 292

the relevant qualifications, training and experience of each inspector. 293

294

8.6 Personnel should have clear, up-to-date and documented job descriptions 295

specifying their duties and responsibilities. 296

297

8.7 When products are procured from a third party and/or services are subcontracted to an 298

external body or expert, the inspectorate should ensure that the third party meets 299

predefined documented criteria, qualifications and the relevant requirements of the 300

quality management system. Senior management should ensure that these 301

external bodies or experts are periodically evaluated. Third party liability should 302

be clearly defined in the contract or agreement. 303

304

8.8 All personnel employed or contracted by the inspectorate should obey the 305

inspectorate’s code of conduct and should not be subject to any commercial, 306

financial or other pressures which might affect their judgement and freedom to 307

act. They should not be under the control of the pharmaceutical industry and 308

must be assessed for potential conflict of interest. Personnel and third-party 309

declarations of conflict of interest should be maintained, reviewed periodically 310


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and updated where necessary. It should be ensured that any decision-making 311

process remains with the inspectorate and is not influenced by any third party 312

313

Infrastructure 314

315

8.9 The inspectorate should provide personnel with the necessary infrastructure and 316

appropriate work environment to support its functions and to enable meeting 317

the quality objectives. Infrastructure includes, but is not limited to: 318

319

a. buildings, workspace, and associated facilities; 320

b. qualified equipment, including hardware and software; 321

c. transportation resources; and 322

d. information and communication technology. 323

324

9. DOCUMENTATION 325

326

9.1 The inspectorate should establish and maintain a system for the control of all 327

documentation, including electronic files, relating to inspectorate’s QMS and activities. 328

This should include policies, procedures, guidelines, records and any documents of 329

external origin, such as legislation, which may directly or indirectly influence the 330

activities of the inspectorate; or documents received from pharmaceutical companies 331

and relevant organizations, as appropriate. 332

333

9.2 The inspectorate should ensure that its functions and operations are described 334

in SOPs that clearly define the responsibilities, processes and actions. These 335

may include, but not be limited to, training, inspections, reporting after 336

inspections, handling of complaints, licensing (issue, suspension, withdrawal), 337

certification, handling of quality, safety and efficacy issues, documentation 338

control, change and deviation management, inspection planning, risk 339

management and the handling of appeals. 340

341

342


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9.3 The system and activities relating to advising on, issue, withdrawal, suspension of 343

licenses, registrations, certifications and the application of other regulatory sanctions 344

on facilities, organizations, products or operations, should be detailed in procedures and 345

be in accordance with relevant guidelines and national legislation. 346

347

9.4 The inspectorate should establish procedures describing communication with other 348

NRA units and external interested parties (e.g. industry, media) considering any 349

statutory and regulatory requirements, where appropriate. Similarly, a procedure for 350

exchanging regulatory information with other NRAs or national quality control 351

laboratories should be available. 352

353

9.5 Activities relating to the sampling and testing of pharmaceutical products and raw 354

materials should be described in a procedure which should also include the process for 355

handling non-conforming products (e.g. substandard or falsified medical products). 356

357

9.6 The inspectorate should have procedures on handling quality, safety and efficacy issues 358

which may lead to recall or the withdrawal of products from the market. Where 359

applicable, the inspectorate should establish and maintain a system for communicating 360

Rapid Alerts. Records of recalls and withdrawals should be maintained in accordance 361

with national legislation. 362

363

9.7 The inspectorate should have documented procedures for dealing with complaints 364

arising from its activities or those of its personnel and any contracted person or 365

organization. A record should be maintained of all complaints received and the actions 366

taken by the inspectorate. These records should be retained for a specified period of 367

time. 368

369

9.8 The inspectorate should have procedures for consideration of appeals against 370

its decisions. 371

372

373

374


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9.9 The documentation control system should ensure that: 375

376

a. Documents are identified by title, author, reviewer, approver and unique 377

identification. They should be dated and authorized by the appropriate persons 378

prior to issue. 379

b. Current versions of documents are held by nominated personnel. 380

c. A register of all relevant documents and document holders should be 381

maintained. 382

d. Superseded documents are withdrawn from use but are retained for defined 383

periods of time. 384

e. Any changes to documents are made in a controlled manner and are properly 385

authorized. There should be a means of identifying changes in individual 386

documents. 387

f. Records relating to inspectorate’s activities and functions are readily available 388

and are retained for an adequate period in line with legal requirements or internal 389

standards. 390

g. Records comply with the relevant obligations under national legislation. 391

h. Records are safely stored during their retention period and held under conditions 392

that guarantee their security and confidentiality unless otherwise required by 393

national legislation. The destruction of records after their retention period 394

follows a predefined procedure. 395

i. Electronic documentation and record management systems should provide at 396

least the same level of assurance, compliance, accuracy and security as a manual 397

system. 398

399

9.10 An inspection should be categorized in accordance with GXP guidelines (e.g. GMP, 400

GDP, GCP) and its scope (e.g. product, process) and type (e.g. triggered, routine, 401

follow-up) should be appropriately defined and documented. 402

403

9.11 The inspectorate should plan inspections in advance and elaborate a written programme 404

as part of the inspectorate’s annual workplan. Risk management principles should be 405

considered when establishing an inspection programme and prioritizing inspections as 406


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well as when conducting an inspection. Where repeated inspections of a company or 407

organization have to be carried out, the frequency should be determined based on risk 408

management principles defined in a procedure. 409

410

9.12 Inspection-related documents and records as defined in relevant inspection procedures 411

(e.g. inspection plan, aide-memoire, checklists, worksheets and company documents 412

and records) should be maintained for a defined period. 413

414

9.13 When more than one inspector is involved in an inspection, a lead inspector should be 415

appointed to coordinate inspection activities. The inspection report should be prepared 416

by the lead inspector with the assistance of all participating inspectors and/or experts 417

and should be agreed upon by all participating inspectors and or experts. 418

9.14 The inspection report should follow a pre-approved format. Observations and/or data 419

obtained in the course of inspection should be recorded in a timely manner in order to 420

prevent loss of relevant information. 421

422

9.15 The inspection report should be sent to the inspected company or organization within 423

the inspectorate’s established timelines. The lead inspector and all concerned 424

inspectors and/or experts should participate in assessing the company’s response to 425

determine the appropriateness of corrective and preventive actions as well as the GXP 426

compliance status of the company or organization. 427

428

9.16 Completed inspections should be reviewed to ensure that requirements are met. 429

430

10. OPERATIONAL PLANNING AND PERFORMANCE EVALUATION 431

432

10.1 An annual workplan should be developed, documented and periodically reviewed by 433

senior management, including all inspectorate’s activities in accordance with a written 434

procedure. Regulatory, statutory and scientific requirements should be taken into 435

account during the planning of operations and services. Consideration should also be 436

given to the availability of required resources and the ability to consistently provide 437

services that meet legislative requirements and stakeholder expectations. Risk 438


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management principles should be used during planning to determine, monitor and 439

manage risks and to identify opportunities for process improvements. Any changes to 440

the workplan should follow the inspectorate’s change management system. 441

442

10.2 Appropriate quality indicators and methods should be established in order to monitor 443

and periodically evaluate the inspectorate’s processes and level of improvement and 444

service (including contracted-out services) and demonstrate that they were carried out 445

as planned and met predefined quality objectives. These quality indicators, methods, 446

analyses and results should be documented. 447

448

10.3 The results of the analyses should be used to evaluate the performance and effectiveness 449

of the QMS, the adequacy of actions taken to address risks and the need for further 450

improvements. 451

452

Internal Audits 453

454

10.4 The inspectorate should implement a system of periodic and documented 455

internal audits of its operations to assess compliance with the requirements of 456

the QMS. Internal audits should be conducted at least once a year. 457

458

10.5 Internal audit processes, criteria, scope and documents should be defined. 459

Auditors qualifications and selection criteria should be documented. Internal 460

audit records, including the findings, conclusions, recommendations and 461

follow-up actions, should be retained for a defined period. 462

463

10.6 Corrective actions corresponding to audit findings should be identified, 464

documented and implemented in a timely manner. The effectiveness of these 465

actions should be evaluated and the risk plan should be updated to take note of 466

the root causes to the non-conformances. 467

468

469

470


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Management Review 471

472

10.7 Senior management should review the inspectorate’s QMS at planned intervals 473

to ensure its continuing suitability, adequacy, effectiveness and alignment with 474

the inspectorate’s strategic direction and legislative requirements. Management 475

reviews should be conducted at least once a year. 476

477

10.8 A management review should include, but not be limited to: 478

479

a. the status of the actions from previous management reviews; 480

b. any internal or external changes affecting the QMS; 481

c. any deviations affecting the functionality of the QMS 482

d. the extent to which quality objectives have been met; 483

e. process performance analyses; 484

f. audit results and effectiveness of corrective actions; 485

g. complaints and appeals; 486

h. adequacy of resources; 487

i. any identified risks and mitigation measures; and 488

j. opportunities for improvements. 489

490

11. PUBLICATIONS 491

492

11.1 The inspectorate should issue and maintain an up-to-date list of inspected and licensed 493

facilities and organizations, including information on the outcome of inspections. This 494

list may become publicly available in accordance with national legislation. 495

496

11.2 The inspectorate should ensure that other relevant publications, such as technical 497

guides, GXP guidelines and regulatory requirements, are publicly available. 498

499

500

501

502


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References 503

504

1. Quality System Requirements for National GMP Inspectorates (WHO Technical 505

Report Series, No. 902, Annex 8, 2002). 506

507

2. Quality Management Systems —Requirements. International Standard ISO 9001. 508

Geneva, International Organization for Standardization, 2015. 509

510

3. Recommendation on Quality System Requirements for Pharmaceutical 511

Inspectorates – Pharmaceutical Inspection Convention/Co-operation Scheme 512

(PIC/S) PI002-3, 2007. 513

514

4. WHO Guideline on the Implementation of Quality Management Systems for 515

National Regulatory Authorities (Working document QAS/19.783). 516

517

Further reading 518

519

1. WHO Good Manufacturing Practices for Pharmaceutical Products: Main 520

Principles. WHO Expert Committee on Specifications for Pharmaceutical 521

Preparations. Forty-eight Report, Geneva, World Health Organization, 2014 522

(WHO Technical Report Series, No. 986 Annex 2). 523

524

2. WHO Good Manufacturing Practices for Active Pharmaceutical Ingredients (WHO 525

Technical Report Series, No. 957, 2010, Annex 2). 526

527

3. WHO Good Practices for Pharmaceutical Quality Control Laboratories (WHO 528

Technical Report Series, No. 957, 2010, Annex 1). 529

530

4. Good Distribution Practices for Pharmaceutical Products (WHO Technical Report 531

Series, No. 957, 2010, Annex 5). Update in progress. Good Storage and 532

Distribution Practices (QAS/19.793). 533

https://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodDistributionPracticesTRS957Annex5.pdf?ua=1


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https://www.who.int/medicines/areas/quality_safety/quality_assurance/qas19_793_534

good_storage_and_distribution_practices_may_2019.pdf?ua=1 (last access 16 July 535

2019). 536

537

5. Good Trade and Distribution Practices for Pharmaceutical Starting Materials 538

(WHO Technical Report Series No. 996, 2016). 539

540

6. Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products 541

(WHO Technical Report Series, No. 850, 1995, Annex 3). 542

543

7. WHO Guideline on the Implementation of Quality Management Systems for 544

National Regulatory Authorities. Working document QAS/19.783, January 2019. 545

546

8. Quality Systems Framework for GMP Inspectorates, Compilation of Community 547

Procedures on Inspections and Exchange of Information - European Commission, 548

EMA/572454/2014 Rev. 17, 2014. 549

550

9. Quality Management Systems – Fundamentals and Vocabulary. International 551

Standard ISO 9000. Geneva, International Organization for Standardization, 2015. 552

553

10. Quality Management - Quality of an Organization - Guidance to Achieve 554

Sustained Success. International Standard ISO 9004. Geneva, International 555

Organization for Standardization, 2018. 556

557

11. Conformity Assessment -- Requirements for the Operation of Various Types of 558

Bodies Performing Inspection. International Standard ISO 17020. Geneva, 559

International Organization for Standardization, 2012. 560

561

12. Risk Management – Guidelines. International Standard ISO 31000. Geneva, 562

International Organization for Standardization, 2018. 563

564

565

https://www.who.int/medicines/areas/quality_safety/quality_assurance/qas19_793_good_storage_and_distribution_practices_may_2019.pdf?ua=1

https://www.who.int/medicines/areas/quality_safety/quality_assurance/qas19_793_good_storage_and_distribution_practices_may_2019.pdf?ua=1


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13. Guidelines for Auditing Management Systems. International Standard ISO 19011. 566

Geneva, International Organization for Standardization, 2018. 567

568

14. Medical Devices – Quality Management Systems – Requirements for Regulatory 569

Purposes. International Standard ISO 13485. Geneva, International 570

Organization for Standardization, 2016. 571

572

15. Pharmaceutical Quality System Q10. International Conference on Harmonization, 573

2008. 574

575

*** 576