IPLC (Gran)

Site conducted

Glatt 500 FBE/DIOSNA 400A<br>(Note: Inspection is only conducted if there is an on-going production)

CLUSTER NUMBER

A. PERSONNEL (Is there any deviations from this category?)

1. Personnel familiar with/adhere to current SOPs

Classification

2. Correct personal hygiene and sanitation practice (No smoking, eating, drinking, chewing, expectorating, taking of medications, bringing in of plant/ food/ drinks/ smoking materials/ personal medicine)

Classification

3. Dress Code (with gloves, mask, safety shoes, if applicable)

Classification

4. Others (indicated other observation not mentioned from the previous questions)

Classification

B. PREMISES (Is there any deviations from this category?)

1. Area free from clutter/ dirt and items not needed in the on-going operation

Classification

2. Good state of repair - no cracks/ holes/ leaks/, peeling/ faded paints

Classification

3. Adequate lighting

Classification

4. Environment monitoring and control of critical areas (RH and Temperature)

Classification

5. No insects, birds, or other animals in the area

Classification

6. Cleaning tools kept in designated storage areas

Classification

7. Maintenance parts and tools kept in designated rooms/ lockers

Classification

8. Pallets - clean and well- maintained and neatly stacked

Classification

Classification

C. EQUIPMENT (Is there any deviations from this category?)

1. Good state of repair/ cleanliness

Classification

2. Appropriate status label (Defective, Under Preventive Maintenance , Under Repair)

Classification

3. Calibration Program (With Calibration certificates/ stickers)

Classification

4. No glass equipment; no wooden furniture and fixtures

Classification

5. Others (indicated other observation not mentioned from the previous questions5

Classification

D. DOCUMENTATION (Is there any deviations from this category?)

1. Batch Records - completely filled-out; complete signatories with dates (Real time recording - no late or advance entries)

Classification

2. Records/ Log Books - clear/ legible/ indelible handwritten entries (a. Alterations - signed and dated; crossed out with a single line, correction written legibly above original entry; b. Entries made at the time each action is done; no transcription from scratch paper)

Classification

3. In-process controls - accurate and "on time" recording

Classification

4. No informal instructions/ unofficial documentation

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

E. PRODUCTION (Is there any deviations from this category?)

1. Adequate line purgation practices - no traces of starting materials, product residues, documents, labels not relevant to the current operations

Classification

2. Proper labeling - component name, item code, control number, weight or measure, pertinent product name/batch number/lot number

Classification

3. Correct Product Identification Board - Product name, Batch number, and Process Checker/ Operator

Classification

4. Others (indicate other observation not mentioned from the previous questions)

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

Midas Micronizer<br>(Note: Inspection is only conducted if there is an on-going production)

CLUSTER NUMBER

A. PERSONNEL (Is there any deviations from this category?)

1. Personnel familiar with/adhere to current SOPs

Classification

2. Correct personal hygiene and sanitation practice (No smoking, eating, drinking, chewing, expectorating, taking of medications, bringing in of plant/ food/ drinks/ smoking materials/ personal medicine)

Classification

3. Dress Code (with gloves, mask, safety shoes, if applicable)

Classification

4. Others (indicated other observation not mentioned from the previous questions)

Classification

B. PREMISES (Is there any deviations from this category?)

1. Area free from clutter/ dirt and items not needed in the on-going operation

Classification

2. Good state of repair - no cracks/ holes/ leaks/, peeling/ faded paints

Classification

3. Adequate lighting

Classification

4. Environment monitoring and control of critical areas (RH and Temperature)

Classification

5. No insects, birds, or other animals in the area

Classification

6. Cleaning tools kept in designated storage areas

Classification

7. Maintenance parts and tools kept in designated rooms/ lockers

Classification

8. Pallets - clean and well- maintained and neatly stacked

Classification

Classification

C. EQUIPMENT (Is there any deviations from this category?)

1. Good state of repair/ cleanliness

Classification

2. Appropriate status label (Defective, Under Preventive Maintenance , Under Repair)

Classification

3. Calibration Program (With Calibration certificates/ stickers)

Classification

4. No glass equipment; no wooden furniture and fixtures

Classification

5. Others (indicated other observation not mentioned from the previous questions5

Classification

D. DOCUMENTATION (Is there any deviations from this category?)

1. Batch Records - completely filled-out; complete signatories with dates (Real time recording - no late or advance entries)

Classification

2. Records/ Log Books - clear/ legible/ indelible handwritten entries (a. Alterations - signed and dated; crossed out with a single line, correction written legibly above original entry; b. Entries made at the time each action is done; no transcription from scratch paper)

Classification

3. In-process controls - accurate and "on time" recording

Classification

4. No informal instructions/ unofficial documentation

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

E. PRODUCTION (Is there any deviations from this category?)

1. Adequate line purgation practices - no traces of starting materials, product residues, documents, labels not relevant to the current operations

Classification

2. Proper labeling - component name, item code, control number, weight or measure, pertinent product name/batch number/lot number

Classification

3. Correct Product Identification Board - Product name, Batch number, and Process Checker/ Operator

Classification

4. Others (indicate other observation not mentioned from the previous questions)

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

Binder Room B<br>(Note: Inspection is only conducted if there is an on-going production)

CLUSTER NUMBER

A. PERSONNEL (Is there any deviations from this category?)

1. Personnel familiar with/adhere to current SOPs

Classification

2. Correct personal hygiene and sanitation practice (No smoking, eating, drinking, chewing, expectorating, taking of medications, bringing in of plant/ food/ drinks/ smoking materials/ personal medicine)

Classification

3. Dress Code (with gloves, mask, safety shoes, if applicable)

Classification

4. Others (indicated other observation not mentioned from the previous questions)

Classification

B. PREMISES (Is there any deviations from this category?)

1. Area free from clutter/ dirt and items not needed in the on-going operation

Classification

2. Good state of repair - no cracks/ holes/ leaks/, peeling/ faded paints

Classification

3. Adequate lighting

Classification

4. Environment monitoring and control of critical areas (RH and Temperature)

Classification

5. No insects, birds, or other animals in the area

Classification

6. Cleaning tools kept in designated storage areas

Classification

7. Maintenance parts and tools kept in designated rooms/ lockers

Classification

8. Pallets - clean and well- maintained and neatly stacked

Classification

Classification

C. EQUIPMENT (Is there any deviations from this category?)

1. Good state of repair/ cleanliness

Classification

2. Appropriate status label (Defective, Under Preventive Maintenance , Under Repair)

Classification

3. Calibration Program (With Calibration certificates/ stickers)

Classification

4. No glass equipment; no wooden furniture and fixtures

Classification

5. Others (indicated other observation not mentioned from the previous questions5

Classification

D. DOCUMENTATION (Is there any deviations from this category?)

1. Batch Records - completely filled-out; complete signatories with dates (Real time recording - no late or advance entries)

Classification

2. Records/ Log Books - clear/ legible/ indelible handwritten entries (a. Alterations - signed and dated; crossed out with a single line, correction written legibly above original entry; b. Entries made at the time each action is done; no transcription from scratch paper)

Classification

3. In-process controls - accurate and "on time" recording

Classification

4. No informal instructions/ unofficial documentation

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

E. PRODUCTION (Is there any deviations from this category?)

1. Adequate line purgation practices - no traces of starting materials, product residues, documents, labels not relevant to the current operations

Classification

2. Proper labeling - component name, item code, control number, weight or measure, pertinent product name/batch number/lot number

Classification

3. Correct Product Identification Board - Product name, Batch number, and Process Checker/ Operator

Classification

4. Others (indicate other observation not mentioned from the previous questions)

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

Sigma Mixer/ Comminuting Machine<br>(Note: Inspection is only conducted if there is an on-going production)

CLUSTER NUMBER

A. PERSONNEL (Is there any deviations from this category?)

1. Personnel familiar with/adhere to current SOPs

Classification

2. Correct personal hygiene and sanitation practice (No smoking, eating, drinking, chewing, expectorating, taking of medications, bringing in of plant/ food/ drinks/ smoking materials/ personal medicine)

Classification

3. Dress Code (with gloves, mask, safety shoes, if applicable)

Classification

4. Others (indicated other observation not mentioned from the previous questions)

Classification

B. PREMISES (Is there any deviations from this category?)

1. Area free from clutter/ dirt and items not needed in the on-going operation

Classification

2. Good state of repair - no cracks/ holes/ leaks/, peeling/ faded paints

Classification

3. Adequate lighting

Classification

4. Environment monitoring and control of critical areas (RH and Temperature)

Classification

5. No insects, birds, or other animals in the area

Classification

6. Cleaning tools kept in designated storage areas

Classification

7. Maintenance parts and tools kept in designated rooms/ lockers

Classification

8. Pallets - clean and well- maintained and neatly stacked

Classification

Classification

C. EQUIPMENT (Is there any deviations from this category?)

1. Good state of repair/ cleanliness

Classification

2. Appropriate status label (Defective, Under Preventive Maintenance , Under Repair)

Classification

3. Calibration Program (With Calibration certificates/ stickers)

Classification

4. No glass equipment; no wooden furniture and fixtures

Classification

5. Others (indicated other observation not mentioned from the previous questions5

Classification

D. DOCUMENTATION (Is there any deviations from this category?)

1. Batch Records - completely filled-out; complete signatories with dates (Real time recording - no late or advance entries)

Classification

2. Records/ Log Books - clear/ legible/ indelible handwritten entries (a. Alterations - signed and dated; crossed out with a single line, correction written legibly above original entry; b. Entries made at the time each action is done; no transcription from scratch paper)

Classification

3. In-process controls - accurate and "on time" recording

Classification

4. No informal instructions/ unofficial documentation

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

E. PRODUCTION (Is there any deviations from this category?)

1. Adequate line purgation practices - no traces of starting materials, product residues, documents, labels not relevant to the current operations

Classification

2. Proper labeling - component name, item code, control number, weight or measure, pertinent product name/batch number/lot number

Classification

3. Correct Product Identification Board - Product name, Batch number, and Process Checker/ Operator

Classification

4. Others (indicate other observation not mentioned from the previous questions)

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

Testing Room<br>(Note: Inspection is only conducted if there is an on-going production)

CLUSTER NUMBER

A. PERSONNEL (Is there any deviations from this category?)

1. Personnel familiar with/adhere to current SOPs

Classification

2. Correct personal hygiene and sanitation practice (No smoking, eating, drinking, chewing, expectorating, taking of medications, bringing in of plant/ food/ drinks/ smoking materials/ personal medicine)

Classification

3. Dress Code (with gloves, mask, safety shoes, if applicable)

Classification

4. Others (indicated other observation not mentioned from the previous questions)

Classification

B. PREMISES (Is there any deviations from this category?)

1. Area free from clutter/ dirt and items not needed in the on-going operation

Classification

2. Good state of repair - no cracks/ holes/ leaks/, peeling/ faded paints

Classification

3. Adequate lighting

Classification

4. Environment monitoring and control of critical areas (RH and Temperature)

Classification

5. No insects, birds, or other animals in the area

Classification

6. Cleaning tools kept in designated storage areas

Classification

7. Maintenance parts and tools kept in designated rooms/ lockers

Classification

8. Pallets - clean and well- maintained and neatly stacked

Classification

Classification

C. EQUIPMENT (Is there any deviations from this category?)

1. Good state of repair/ cleanliness

Classification

2. Appropriate status label (Defective, Under Preventive Maintenance , Under Repair)

Classification

3. Calibration Program (With Calibration certificates/ stickers)

Classification

4. No glass equipment; no wooden furniture and fixtures

Classification

5. Others (indicated other observation not mentioned from the previous questions5

Classification

D. DOCUMENTATION (Is there any deviations from this category?)

1. Batch Records - completely filled-out; complete signatories with dates (Real time recording - no late or advance entries)

Classification

2. Records/ Log Books - clear/ legible/ indelible handwritten entries (a. Alterations - signed and dated; crossed out with a single line, correction written legibly above original entry; b. Entries made at the time each action is done; no transcription from scratch paper)

Classification

3. In-process controls - accurate and "on time" recording

Classification

4. No informal instructions/ unofficial documentation

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

E. PRODUCTION (Is there any deviations from this category?)

1. Adequate line purgation practices - no traces of starting materials, product residues, documents, labels not relevant to the current operations

Classification

2. Proper labeling - component name, item code, control number, weight or measure, pertinent product name/batch number/lot number

Classification

3. Correct Product Identification Board - Product name, Batch number, and Process Checker/ Operator

Classification

4. Others (indicate other observation not mentioned from the previous questions)

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

Gemco 60 #1<br>(Note: Inspection is only conducted if there is an on-going production)

CLUSTER NUMBER

A. PERSONNEL (Is there any deviations from this category?)

1. Personnel familiar with/adhere to current SOPs

Classification

2. Correct personal hygiene and sanitation practice (No smoking, eating, drinking, chewing, expectorating, taking of medications, bringing in of plant/ food/ drinks/ smoking materials/ personal medicine)

Classification

3. Dress Code (with gloves, mask, safety shoes, if applicable)

Classification

4. Others (indicated other observation not mentioned from the previous questions)

Classification

B. PREMISES (Is there any deviations from this category?)

1. Area free from clutter/ dirt and items not needed in the on-going operation

Classification

2. Good state of repair - no cracks/ holes/ leaks/, peeling/ faded paints

Classification

3. Adequate lighting

Classification

4. Environment monitoring and control of critical areas (RH and Temperature)

Classification

5. No insects, birds, or other animals in the area

Classification

6. Cleaning tools kept in designated storage areas

Classification

7. Maintenance parts and tools kept in designated rooms/ lockers

Classification

8. Pallets - clean and well- maintained and neatly stacked

Classification

Classification

C. EQUIPMENT (Is there any deviations from this category?)

1. Good state of repair/ cleanliness

Classification

2. Appropriate status label (Defective, Under Preventive Maintenance , Under Repair)

Classification

3. Calibration Program (With Calibration certificates/ stickers)

Classification

4. No glass equipment; no wooden furniture and fixtures

Classification

5. Others (indicated other observation not mentioned from the previous questions5

Classification

D. DOCUMENTATION (Is there any deviations from this category?)

1. Batch Records - completely filled-out; complete signatories with dates (Real time recording - no late or advance entries)

Classification

2. Records/ Log Books - clear/ legible/ indelible handwritten entries (a. Alterations - signed and dated; crossed out with a single line, correction written legibly above original entry; b. Entries made at the time each action is done; no transcription from scratch paper)

Classification

3. In-process controls - accurate and "on time" recording

Classification

4. No informal instructions/ unofficial documentation

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

E. PRODUCTION (Is there any deviations from this category?)

1. Adequate line purgation practices - no traces of starting materials, product residues, documents, labels not relevant to the current operations

Classification

2. Proper labeling - component name, item code, control number, weight or measure, pertinent product name/batch number/lot number

Classification

3. Correct Product Identification Board - Product name, Batch number, and Process Checker/ Operator

Classification

4. Others (indicate other observation not mentioned from the previous questions)

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

Glatt 500 FBE PRO<br>(Note: Inspection is only conducted if there is an on-going production)

CLUSTER NUMBER

A. PERSONNEL (Is there any deviations from this category?)

1. Personnel familiar with/adhere to current SOPs

Classification

2. Correct personal hygiene and sanitation practice (No smoking, eating, drinking, chewing, expectorating, taking of medications, bringing in of plant/ food/ drinks/ smoking materials/ personal medicine)

Classification

3. Dress Code (with gloves, mask, safety shoes, if applicable)

Classification

4. Others (indicated other observation not mentioned from the previous questions)

Classification

B. PREMISES (Is there any deviations from this category?)

1. Area free from clutter/ dirt and items not needed in the on-going operation

Classification

2. Good state of repair - no cracks/ holes/ leaks/, peeling/ faded paints

Classification

3. Adequate lighting

Classification

4. Environment monitoring and control of critical areas (RH and Temperature)

Classification

5. No insects, birds, or other animals in the area

Classification

6. Cleaning tools kept in designated storage areas

Classification

7. Maintenance parts and tools kept in designated rooms/ lockers

Classification

8. Pallets - clean and well- maintained and neatly stacked

Classification

Classification

C. EQUIPMENT (Is there any deviations from this category?)

1. Good state of repair/ cleanliness

Classification

2. Appropriate status label (Defective, Under Preventive Maintenance , Under Repair)

Classification

3. Calibration Program (With Calibration certificates/ stickers)

Classification

4. No glass equipment; no wooden furniture and fixtures

Classification

5. Others (indicated other observation not mentioned from the previous questions5

Classification

D. DOCUMENTATION (Is there any deviations from this category?)

1. Batch Records - completely filled-out; complete signatories with dates (Real time recording - no late or advance entries)

Classification

2. Records/ Log Books - clear/ legible/ indelible handwritten entries (a. Alterations - signed and dated; crossed out with a single line, correction written legibly above original entry; b. Entries made at the time each action is done; no transcription from scratch paper)

Classification

3. In-process controls - accurate and "on time" recording

Classification

4. No informal instructions/ unofficial documentation

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

E. PRODUCTION (Is there any deviations from this category?)

1. Adequate line purgation practices - no traces of starting materials, product residues, documents, labels not relevant to the current operations

Classification

2. Proper labeling - component name, item code, control number, weight or measure, pertinent product name/batch number/lot number

Classification

3. Correct Product Identification Board - Product name, Batch number, and Process Checker/ Operator

Classification

4. Others (indicate other observation not mentioned from the previous questions)

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

Gemco 30 #1<br>(Note: Inspection is only conducted if there is an on-going production)

CLUSTER NUMBER

A. PERSONNEL (Is there any deviations from this category?)

1. Personnel familiar with/adhere to current SOPs

Classification

2. Correct personal hygiene and sanitation practice (No smoking, eating, drinking, chewing, expectorating, taking of medications, bringing in of plant/ food/ drinks/ smoking materials/ personal medicine)

Classification

3. Dress Code (with gloves, mask, safety shoes, if applicable)

Classification

4. Others (indicated other observation not mentioned from the previous questions)

Classification

B. PREMISES (Is there any deviations from this category?)

1. Area free from clutter/ dirt and items not needed in the on-going operation

Classification

2. Good state of repair - no cracks/ holes/ leaks/, peeling/ faded paints

Classification

3. Adequate lighting

Classification

4. Environment monitoring and control of critical areas (RH and Temperature)

Classification

5. No insects, birds, or other animals in the area

Classification

6. Cleaning tools kept in designated storage areas

Classification

7. Maintenance parts and tools kept in designated rooms/ lockers

Classification

8. Pallets - clean and well- maintained and neatly stacked

Classification

Classification

C. EQUIPMENT (Is there any deviations from this category?)

1. Good state of repair/ cleanliness

Classification

2. Appropriate status label (Defective, Under Preventive Maintenance , Under Repair)

Classification

3. Calibration Program (With Calibration certificates/ stickers)

Classification

4. No glass equipment; no wooden furniture and fixtures

Classification

5. Others (indicated other observation not mentioned from the previous questions5

Classification

D. DOCUMENTATION (Is there any deviations from this category?)

1. Batch Records - completely filled-out; complete signatories with dates (Real time recording - no late or advance entries)

Classification

2. Records/ Log Books - clear/ legible/ indelible handwritten entries (a. Alterations - signed and dated; crossed out with a single line, correction written legibly above original entry; b. Entries made at the time each action is done; no transcription from scratch paper)

Classification

3. In-process controls - accurate and "on time" recording

Classification

4. No informal instructions/ unofficial documentation

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

E. PRODUCTION (Is there any deviations from this category?)

1. Adequate line purgation practices - no traces of starting materials, product residues, documents, labels not relevant to the current operations

Classification

2. Proper labeling - component name, item code, control number, weight or measure, pertinent product name/batch number/lot number

Classification

3. Correct Product Identification Board - Product name, Batch number, and Process Checker/ Operator

Classification

4. Others (indicate other observation not mentioned from the previous questions)

Classification

5. Others (indicated other observation not mentioned from the previous questions)

Classification

Grall 1200/Aeromatic Dryer/Comminuting Machine/Binder Room A<br>(Note: Inspection is only conducted if there is an on-going production)