chapter 3 of gdp requirements : premises & …...1. chapter 3 : premises and equipment...

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Chapter 3 of GDP Requirements : Premises & Equipment COOL SUPPLY SYSTEM & SOLUTIONS

19th and 20th of March 2015

Riekert Bruinink

GMP/GDP inspector

Dutch Healthcare Inspectorate

1. Chapter 3 : Premises and Equipment

•Wholesale distributors should have suitable and adequate

premises, installations and equiment, as so to ensure proper

storage and distribution of medicinal products. In particular

the premises should be clean, dry and maintained within

acceptable temperature limits.

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1. Premises and equipment ( Chapter 3 )

• Premises : construction / separation of goods

• Temperature mapping

• Equipment : maintenance / repair /calibration

• Computerised Systems validation

• Qualification and validation key equipment


Agenda

1. Premises

2. Temperature management

3. Qualification and validation

4. Cases


1. Premises

• Suitable and adequate

• Sufficient capacity

• Receiving and dispatch bays should protect

• Adequate separation of goods

• Receiving / dispatch /storage area

• Narcotic drugs / hazardous goods

• Unauthorised acces should be prevented


1. Premises : Construction / Capacity

•The premises should be suitable, structurally sound, provided

• with adequate lighting and of sufficient capacity..


1. Premises : capacity / appropriate storage ( at the right)


1. Premises : receiving / dispatch products

•Receiving bays and dispatch bays should protect products from

prevailing weather conditions

• Unloading and loading products can have influence on

temperature


1. Chapter 3 : Separation of goods

• Separation either physically or through an equivalent validated

electronic system ( general rule with exceptions)

• Chapter 3/5 - stored separately from other

products likely to alter them

- stored physically apart and

based on validated system

for rejected , expired and

recalled products;

- for falsified medicinal products

and returns as well.

- dedicated on hold area

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1. Premises : Which area’s are necessary ?

• Receiving area

• Storage area

• On hold area

• Dispatch area

• Rest,wash refreshment rooms

• Offices

• Separation inbound /outbound

during the day


1. Chapter 3 : Narcotics / Hazardous products

• Radioactive materials / hazardous products

• Narcotic drugs

• Part of National Laws and International Rules

• Differences between Member States


2. Temperature management

• System for heating/cooling

• Temperature mapping : how long, where, when ?

• Temperature monitoring at the right places

• Control temperature periodically

• Appropriate alarm system

• Managing alarms / excursions


2. Temperature mapping

• Why : temperature behavior varies

• What : freezers, refrigerators , storage area for

ambient products , trucks etc.

• How ? : Measuring temperature at several locations

on a three dimensional plain.


2.Temperature mapping

• When : initial before using a storage facility

summer / winter (OQ/PQ)

after significant changes

risk based

• Start : identify places which a higher or lower

temperature : heaters, doors , windows etc.

• How long : At least 2 days/ one week


2. Temperature mapping

• Results : temperature data

warmest/coldest places

• Conclusion : Temperature within specification ?

Warmest / coldest spots ?

Place monitoring devices

Storage may be not possible at certain places

• Rapport : Method/ findings/ conclusions


2. Temperature management : Results of GDP inspections

• Results : Monitoring , registration, control : 94 % .

Weak system : 18%

Temperature mapping : 62 %

Temperature mapping (S and W) : 27%

Alarm system : 65 %

Follow-up alarm :50 %

• Remarks : Sometimes only one device

Sometimes temperature excursions

without actions ; alarms on temperature

monitoring device.

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• Identify what key equipment and/or key process

qualification / validation is necessary.

• The scope and extend should be determined

using a risk assessment approach.

• Efforts should be established in the validation

master plan.


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3. Qualification /Validation : examples

3. Qualification and Validation : examples

• Temperature behaviour building

• Temperature behaviour cool area

• Air handling units

• Access control

• Alarm systems

• Safety and security systems

• Processes : for example handling cool storage products

• Transportation (company)



• Computerized systems should be validated accor-

ding to approved protocols prior to their use.

• Systems already in place should also be validated.

• The extend depends on the risk to or impact of

the software on product or service quality.

• It isn’t applied to software that has no impact

on quality.


3. Qualification and Validation



• A written description of the system should be in

place.

• The document should describe principles,

objectives, security measures , how it is used etc.

• Authorization

• Make a back up at regular intervals


3. Qualification and validation : QA and ICT!


4. Case Facilities

Case : medium wholesaler with their own storage facilities

Deficiencies

• Some loading bays and one ‘ open door ‘

• Temperature too low during winter near this door

• Status of some products not clear

• On hold area not present ; storage only based on

the validated warehouse management system


4. Case temperature mapping

Case : wholesaler with a report of a winter temperature

mapping (15-25 ); method and results described

Deficiencies

• Temperature mapping only in winter

• No conclusion at all

• No conclusion about places of continuous monitoring

• Lowest and highest temperatures not mentioned, only graphics

• No identification places with risk before mapping


4. case : insufficient qualification of transportation companies

Case : Inspection parallel wholesale distributor 2014

- transportation national and international in EU by 5

companies

- cold chain and ambient products

- 600 products registrations

Result

• Major deficiency for qualification of transportation companies


4.Case :insufficient qualification of transportation

Questions

• Audits performed ? : No only one visit

• Signed contracts available ? : 3 contracts / 1 sufficient

• Quality of the contracts ? : one contract without quality/GDP

appointments

use of sub-contractors ?

temperature mapping trucks?

• Do you have damaged goods ?: regularly with one company /

problems with financial claims


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