Anexo 5 - MP POP 30-033
Preliminary Inspection Route
1. GENERAL INFORMATION
1.1 Company’s Name:
______
1.2 Address:
______
1.3 Commercial address:
______
1.4 Power of attorney’s name:
______
1.5 Complementary regulatory documents. Please attach in this form each document below:
GMP certificate: no______
ISO 9000 certificate: no______
Others: ______
1.6 Contact names and positions:
______
______
______
1.7 Does the company outsource any kind of products or services?
______
1.7.1 To which activities?
______
1.7.2 Which companies with?
______
1.8 Does the company handle substances like cephalosporin, antibiotics, substances under special control, hormones, antiretroviral, penicillin, cytostatics, pesticides, or others substances highly potency that needs a special control? Which one?
______
1.9 Are the raw materials supplied, can be deriving from other buildings? In affirmative case, which one?
______
2. QUALITY CERTIFICATES
2.1 Do you have Quality Certificate for the products (ISO 9000)? Which one? Please describe it above and attach it in this form.
______
2.2 Do you have Quality Certificate for GMP? Please describe it above and attach it in this form.
______
3 ORGANIZATIONAL
3.1 Number of employees:
Administratives: ______
Professionals: ______
Technicians: ______
Operacionals: ______
Others: ______
Total: ______
3.2 Does the company have any organization chart?
Yes No
3.3 Are there any position descriptions?
Yes No
3.4 Are the responsibilities for the positions clearly defined?
Yes No
3.5 Is the responsible always present?
Yes No
3.6 Production responsible person:
Name: ______
Graduation/ Major: ______
Position: ______
Phone number: ______
3.7 Responsible for the Quality Control:
Name: ______
Graduate/ Major: ______
Position: ______
Phone number:______
3.8 Is there an initial and continuous training program for the employees?
Yes No
3.9 When an employee is hired does he/ she have a health test?
Yes No
3.10 Are health test done periodically to the employees and are there areas that can trigger any kind of disease?
Yes No
3.11 If the employees show any kind of disease that can affect the quality of the product is he/ she taken away from work?
Yes No
3.12 Is there any company policy that defines who decides the temporary leave of worker?
Yes No
3.13 Is there a nursery room?
Yes No
4 INSTALATIONS
4.1 Is the building suitable for the production?
Yes No
4.2 Are the sterile products or any other that need isolated or separated areas made in the plant?
Yes No
4.3 What is the total build area? ______
4.4 What is the total land area? ______
4.5 Are the areas around the factory cleaned?
Yes No
4.6 Are the roads suitable?
Yes No
4.7 Are there enough bathrooms?
Yes No
4.8 Are the bathrooms cleaned and will it gear?
Yes No
4.9 Is there a restaurant or cafeteria in the place?
Yes No
4.10 Are the buildings in good state outside?
Yes No
4.11 Are the walls, floors and ceilings built with material suitable to the manufacturing process
Yes No
4.12 Are the sewers, guts and plumbing in good state?
Yes No
4.13 Are there drains (siphon)?
Yes No
4.14 Are the water and other fluids storage and distribution installation suitably identified?
Yes No
5 – CUSTOMERS LIST
5.1 Could you please inform us some main customers?
______
______
______
______
______
______
______
______
______, ______
city month day year
______
Signature and company’s stamp
I declare, for all the ends that the information upon had been given with exactness, veracity and good faith and I am authorized to act in the subjects of the present document.
Anexo 6 - MP POP 30-033
Raw Material Check – List
CLASSIFICATION CRITERIA FOR THE CHECK–LIST ITEMS:
Overall Rating
I Essential
N Necessary
R Recommendable
INF Informative
APPLICATION CRITERIA FOR THE CHECK – LIST ITEMS:
A – Applicable
NA – Not Applicable
We would like to ask you not to fill in the spaces referring to “Rate” and “Total”, just fill in the brackets.
Item
/ Classi-fication/ Rank /Application
/ Rate / TotalI – QUALITY ASSURANCE SYSTEM
1. Is there a documented, implemented and consolidated quality system? / I (3) / - Is the System documented?yes ( ) no ( )
- Is it documented and implemented
yes ( ) no ( )
- Is it documented, implemented and consolidated?
yes ( ) no ( )
2. Is there a project defined by the board of directors for the implementation of a quality system? / I (3) / Yes ( ) No ( )
3. Is there a periodic updated control of the documents? / I (3) / Yes ( ) No ( )
4. Is there a periodic monitoring to the sub supplier? Are there any records? / R (1) / Yes ( ) No ( )
5. Is the lot documentation easy to be found? Is it available during the expiring date? / I (3) / Yes( ) No ( )
6.Does the existing documentation allow the raw material supplier to be found? / I (3) / Yes ( ) No ( )
7.Is the no conform material identified as it must be and also, is it kept in a specific separated area? / I (3) / - Is the material only identified as non conform?
yes ( ) no ( )
- Is the material only separated in a delimited area?
yes ( ) no ( )
- Is the material only separated in an identified area?
yes ( ) no ( )
-It’s in conformity with
yes ( ) no ( )
8. Are there written procedures in order to direct the nonconformity materials? / I (3) / Yes ( ) No ( )
9. What is the destination given to the nonconformity material, regarding its use, process and/ or customers return? Are there any records? / N (2) / - Is there a destination record?
( ) Yes ( ) No
Describe the destination:
10. Does the analysis certificate follow the product when it is delivered to the customer? / I (3) / Yes ( ) No ( )
11. Are in the analysis certificate registered: the tests specified by the customer, the expiring date, the manufacturing date and the lot number? / I (3) / - Is it in conformity with all the item?
yes ( ) no ( ) or
- Is it in conformity only with:
. specified tests ( );
. expiring date
( );
. manufacturing date
( );
. lot number ( )
12. When noticing quality deviation during the process, is the customer previously informed, in order not to authorize the material? Are there any records? / N (2) / Yes ( ) No ( )
Are there records?
Yes ( ) No ( )
13. When any process alteration occurs, is it recorded? / N (2) / Yes ( ) No ( )
14. Are there any records from the customer complaints? / N (2) / Yes ( ) No ( )
15. Is there a written record of how to deal with the complaints? / N (2) / Yes ( ) No ( )
16. Are the actions taken, related to the complaint and returning of raw material documented? / N (2) / Yes ( ) No ( )
17. Is an internal auditing program carried out? / R (1) / Yes ( ) No ( )
18. Is there a written procedure to do the internal auditing? Are there any records? / R (1) / Is there a written procedure?
Yes ( ) No ( )
- Are there records?
Yes ( ) No ( )
19. Are there written procedures for the operational training and the employees recycling? Are there any records? / N (2) / - Is it in conformity with all the item?
yes ( ) No ( );
- Is there a written procedure?
Yes ( ) No ( )
- Is there a daily basis operation ?
Yes ( ) No ( )
- Is there any record?
Yes ( ) No ( )
20. Is the final product, packaged following the customers specifications? / N (2) / Yes ( ) No ( )
21. Is the packaging material reused? / INF (1) / Yes ( ) No ( )
22.If yes, are there validated procedures for the cleaning and sanitation that guarantee its integrity? / I (3) / Yes ( ) No ( )
23. Are there products delivered in bulk to the customer? / INF (1) / Yes ( ) No ( )
24.Are there written procedures of sanitation for truck tanks that guarantee the integrity (physical, chemical and microbiologic) of the raw material? Are there any records? / I (3) / - Is it in conformity with all the item?
yes ( ) No ( );
- Is there a written procedure?
Yes ( ) No ( )
- Is there a daily basis operation?
Yes ( ) No ( )
- Is there any record?
Yes ( ) No ( )
25. Is there a written procedure for the developing of suppliers/ materials? / N (2) / Yes ( ) No ( )
26. Is there an approved suppliers list? / N (2) / Yes ( ) No ( )
27. Is there a written procedure to follow the approved suppliers performance? Are there any records? / N (2) / - Is it in conformity with all the item?
yes ( ) No ( );
-Is there a written procedure?
Yes ( ) No ( )
- Is there a daily basis operation?
Yes ( ) No ( )
28. Is there a delimited or restrict area for storage returned/ retired products? / N (2) / Yes ( ) No ( )
29. Are the returned products identified as it must be? / N (2) / Yes ( ) No ( )
30. Are the returned products inspected or analyzed before the final destination? / N (2) / Yes ( ) No ( )
31. Are the actions taken can include the possibility of retire the products? Are there any records? / N (2) / - Is it in conformity with all the item?
yes ( ) No ( );
- Is there a written procedure?
Yes ( ) No ( )
- Is there a daily basis operation?
Yes ( ) No ( )
- Is there any record?
Yes ( ) No ( )
32. Is there a stability study program for commercial products? / R (1) / Yes ( ) No ( )
33. Is there a Validation Master Plan? / INF (1) / Yes ( ) No ( )
34. Is the Validation Master Plan complete, including: Responsibilities, Periodicities of Revalidations, Cleaning, Training and Cross References? / R (2) / Yes ( ) No ( )
35. Are there compatibility tests among primary package and product? / R (1) / Yes ( ) No ( )
II – INSTALLATIONS, ENVIRONMENTAL PROTECTION AND SAFETY
1. Is the painting inside and outside the premises in good state? / R (1) / Yes ( ) No ( )Partially Yes ( )
2. Are the water, steam, gas, compressed air pipes and electricity conduit properly identified? / N (2) / Yes ( ) No ( )
3. Are the indoor and outdoor areas well cleaned and sanitized? / N (2) /
Yes ( ) No ( )
4. Are there written procedures for the cleaning and sanitation of the production area, the stockroom and laboratories? / R (1) / Is it in conformity with all the item?
yes ( ) No ( );
- Is there a daily basis operation?
Yes ( ) No ( )
- Is there a written procedure?
Yes ( ) No ( )
5. Are the walls, floors and ceilings built with suitable materials to the manufacturing process? / N (2) / Yes ( ) No ( )
6. Do the installations offer protection against dust, insects, birds and /or rodents? / N (2) / Yes ( ) No ( )
7. Are the pest, plague and rat control programs documented? / N (2) / Yes ( ) No ( )
8. Are there safety systems? Are there records? / R (1) / Yes ( ) No ( )
Are there records?
Yes ( ) No ( )
9. Do the employees wear PPE’s (Personal Protection Equipment)? Is it suitable for the process? / R (1) / Yes ( ) No ( )
10. Does the working place have suitable ventilation and light? / N (2) / Yes ( ) No ( )
11. Are there identified and delimited areas for receiving the materials? / N (2) / - Is it in conformity with all the item?
yes ( ) No ( );
- Is the area identified?
Yes ( ) No ( )
- Is the area delimited?
yes ( )No ( )
12. Is there an identified, delimited/ or separated area for stocking the raw material? / N (2) / - Is it in conformity with all the item?
yes ( ) No ( );
- Is the area identified?
yes ( ) no ( )
- Is the area delimited? yes ( ) no ( )
13. Is there an identified and delimited area for the production? / N (2) / - Is it in conformity with all the item?
yes ( ) no ( );
- Is the area identified?
yes ( ) no ( )
- Is the area delimited?
yes ( ) no ( )
14. Is there an identified and delimited and/ or separated area for storage the not finished products? / N (2) / - Is it in conformity with all the item?
yes ( ) no ( );
- Is the area identified?
yes ( ) no ( )
- Is the area delimited?
yes ( ) no ( )
15. Is there an identified and delimited and/ or separated area for storage the finished products? / N (2) / - Is it in conformity with all the item?
yes ( ) no ( )
- Is the area identified? yes ( ) no ( )
- Is the area delimited? yes ( ) no ( )
16. Is there a suitable identified, delimited and/ or separated area for the storage of toxic, harmful, inflammable, narcotic and/or psychotropic material? Are these areas used exclusively for its purpose / I (3) / - Is it in conformity with all the item?
yes ( ) no ( );
- Is the area identified?
yes ( ) no ( );
- Is the area delimited yes ( ) no ( )
- Is the area used exclusively for its purposes?
yes ( ) no ( )
17. Are trash cans identified, properly, closed and in enough numbers? / N (2) / Yes ( ) No ( )
18. Are the dressing rooms and bathrooms cleaned? Are there proper places, like lockers, to keep objects and clothes? / N (2) / Yes ( ) No ( )
19. Are the dressing rooms, bathrooms and canteen separated from the production area? / N (2) / Yes ( ) No ( )
20. Is there an environmental protection policy, besides the local legislation? / INF (1) / Yes ( ) No ( )
21. Does the canteen organic waste
have a proper storage and destination? / N (2) / Yes ( ) No ( )
22. Do the hazardous residues from the products (e.g. Solvents from the processing or analysis) have a proper destination? / N (2) / Yes ( ) No ( )
23. Are the installations for storage and distribution of water and other fluids properly identified? / INF (1) / Yes ( ) No ( )
III – MATERIALS RECEIPT, DISPATCH AND STORAGE SYSTEM
1. Are there written procedures for the inspection when receiving the materials that check the material physically and fiscally / I (3) / - Is it in conformity with all the item?