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124 • similar capabilities between the SU and RU, including but not limited to, facilities and
125 equipment;
126 • knowledge of the differences in process ability between the SU and RU, including the
127 impact, risk and control strategies to overcome any differences;
128 • an adequate number of adequately trained personnel with suitable qualifications and
129 experience; and
130 • effective process and product knowledge management.
131
132 1.7. A technology transfer should include relevant documentation, data, information and
133 knowledge from the SU in order to enable the RU to effectively execute the specified process
134 or procedure in, for example, production and QC. A successful transfer of technology should
135 result in documented evidence that the RU can routinely reproduce the transferred product,
136 process or procedure against a predefined set of specifications as agreed between the SU and
137 RU.
138
139 1.8. This document should be read in conjunction with other WHO guidelines as referenced below
140 (2-15), as well as other regulatory guidelines which include The International Council for
141 Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7, Q8,
142 Q9, Q10, Q11 and Q12. This guideline does not intend to replace any of these guidelines.
143
144 1.9. This version of the document provides guiding principles reflecting current good practices (GxP)
145 in the transfer of technology and replaces the previous version published by WHO (1).
146

147 2. Scope
148
149 2.1. This document provides guiding principles on the transfer of technology. The principles apply
150 to investigational products as well as marketed products.
151
152 2.2. Throughout development life cycle stages, transfers should be appropriate and proportionate
153 to the phase of the development program to ensure product development knowledge is
154 maintained and processes are appropriately controlled. This guideline should be applied when
155 transferring the technology of manufacturing processes and analytical procedures relating to
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156 active pharmaceutical ingredients (APIs), isolated API intermediates, bulk drug products and
157 finished pharmaceutical products (FPPs).
158
159 2.3. The guideline applies to all pharmaceutical dosage forms and may be adapted on a case-by-
160 case basis by using risk management principles. Particular attention should be given to certain
161 complex formulations.
162
163 2.4. Although this document focuses on pharmaceutical products, the principles can also be applied
164 to the transfer of production, related processes and controls for other products such as
165 biopharmaceutical products, advanced therapy medicinal products/cellular and gene therapy
166 products, vaccines, medical devices and vector control products.
167
168 2.5. Because each transfer project is unique, the provision of a comprehensive set of guidelines
169 specific to a product or process is beyond the scope of this document.
170
171 2.6. This document does not provide guidance on any intellectual property, legal, financial or
172 commercial considerations associated with technology transfer projects. These are
173 prerequisites for a successful transfer that need to be defined and controlled prior the transfer
174 in the course of due diligence. Examples include Health, Safety and Environmental (HSE)
175 Aspects and the availability of a Confidentiality Disclosure Agreements which should be in place
176 prior to the start of the transfer.
177
178 2.7. This document addresses the following principal areas:
179 • organization and management of the transfer;
180 • transfer of relevant information in production, including but not limited to processing,
181 packaging and analytical procedures;
182 • documentation, premises, equipment;
183 • personnel qualification and training;
184 • quality management and risk management;
185 • change management and life cycle approach;
186 • control strategy; and
187 • qualification and validation.
188
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189 3. Glossary
190
191 The definitions given below apply to the terms used in these guidelines. They have been aligned as much
192 as possible with the terminology in related WHO guidelines and GxP and included in the WHO Quality
193 Assurance of Medicines Terminology Database - List of Terms and related guideline
194 https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/mqa-
195 terminology-sept-2020.pdf?sfvrsn=48461cfc_5), but may have different meanings in other contexts.
196
197 acceptance criteria. Measurable terms under which a test result will be considered acceptable.
198
199 active pharmaceutical ingredient (API). Any substance or mixture of substances intended to be used
200 in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active
201 ingredient of that pharmaceutical dosage form. Such substances are intended to furnish
202 pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or
203 prevention of disease, or to affect the structure and function of the body.
204
205 ALCOA+. A commonly used acronym for “attributable, legible, contemporaneous, original
206 and accurate that puts additional emphasis on the attributes of being complete, consistent, enduring
207 and available – implicit basic ALCOA principles.
208
209 bracketing. An experimental design to test the extremes of, for example, dosage strength. The design
210 assumes that the extremes will be representative of all the samples between the extremes.
211
212 change control. A formal system by which qualified representatives of appropriate disciplines review
213 proposed or actual changes that might affect a validated status. The intent is to determine the need
214 for action that would ensure that the system is maintained in a validated state.
215
216 confirmation testing. An execution of tests that confirm and validate the results obtained by another.
217
218 control strategy. A planned set of controls, derived from current product and process understanding
219 that assures process performance and product quality. The controls can include parameters and
220 attributes related to active pharmaceutical ingredient (API) and finished pharmaceutical product (FPP)
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221 materials and components, facility and equipment operating conditions, in-process controls, finished
222 product specifications and the associated methods and frequency of monitoring and control.
223
224 corrective action. Any action to be taken when the results of monitoring at a critical control point
225 indicate a loss of control.
226
227 critical. Having the potential to impact on product quality or performance in a significant way.
228
229 design space. The multidimensional combination and interaction of input variables (e.g. material
230 attributes) and process parameters that have been demonstrated to provide assurance of quality.
231
232 drug master file. Detailed information concerning a specific facility, process, packaging material or
233 product submitted to the medicines regulatory authority, intended for incorporation into the
234 application for marketing authorization.
235
236 finished pharmaceutical product (FPP). A product that has undergone all stages of production,
237 including packaging in its final container and labelling. An FPP may contain one or more active
238 pharmaceutical ingredients (APIs). In some cases, it may be in combination with a medical device.
239
240 gap analysis. The identification of the critical elements of a process which are available at the sending
241 unit (SU) but are missing from the receiving unit (RU) with the objective to assess which gaps have
242 potential impact on the process or method and to mitigate those gaps, as appropriate.
243
244 good manufacturing practices (GMP). That part of quality assurance which ensures that pharmaceutical
245 products are consistently produced and controlled to the quality standards appropriate to their
246 intended use and as required by the marketing authorization.
247
248 in-process control (IPC). Checks performed during production in order to monitor and, if necessary, to
249 adjust the process to ensure that the product conforms to its specifications. The control of the
250 environment or equipment may also be regarded as a part of in-process control.
251
252
253
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254 installation qualification (IQ). Documented verification that the installations (such as machines
255 equipment and instruments, computer system components, measuring devices, utilities and
256 manufacturing) used in a processor system are appropriately selected and correctly installed, in
257 accordance with established specifications.
258
259 intercompany transfer. A transfer of technology between the sites of different companies.
260
261 intracompany transfer. A transfer of technology between sites of the same group of companies.
262
263 operational qualification (OQ). Documented verification that the system or subsystem performs as
264 intended over all anticipated operating ranges.
265
266 performance qualification (PQ). Documented verification that the equipment or system performs
267 consistently and reproducibly within defined specifications and parameters in its normal operating
268 environment (e.g. in the production environment).
269
270 process validation. The collection and evaluation of data, from the process design stage through to
271 commercial production, which establishes scientific evidence that a process is capable of consistently
272 delivering the active pharmaceutical ingredient (API) or finished pharmaceutical product (FPP) meeting
273 its predetermined specifications and quality attributes.
274
275 qualification. Documented evidence that premises, systems or equipment are able to achieve the
276 predetermined specifications when properly installed and/or work correctly and lead to the expected
277 results.
278
279 quality assurance (QA). “Quality assurance” is a wide-ranging concept covering all matters that
280 individually or collectively influence the quality of a product. It is the totality of the arrangements made
281 with the objective of ensuring that pharmaceutical products are of the quality required for their
282 intended use.
283
284 quality control (QC). All measures taken, including the setting of specifications, sampling, testing and
285 analytical clearance, to ensure that starting materials, intermediates, packaging materials and finished