Self Inspection Check List (Production Area)

 Annexure –  VI  Self Inspection Check List (Production Area)

Sr. No.	Check Points		Yes / No	Remarks
Personnel entry
1	Is access to the department restricted to authorized personnel only		Yes / No
2	Check the Cleanliness of area, change room and linen counter.		Yes / No
3	Ask one person to follow the gowning procedures and check for the correctness.		Yes / No
4	Open 2-3 lockers and check any unwanted material is kept in the lockers.		Yes / No
General Area
1	Check for the cleanliness of process corridor and rooms. Check the correctness of cleaning record.		Yes / No
2	Are the floors, walls and ceiling smooth clean and free from cracks, leaks and peeling paint?		Yes / No
3	Are the equipment tops properly clean and free from dust?		Yes / No
4	Are all major equipments distinctively identified and recorded on BMR?		Yes / No
5	Check for adequate lighting for easy operation.		Yes / No
6	Check that all process rooms status labels are properly filled and indicate the current status of the room.		Yes / No
7	Check that operations in the rooms are dust free.		Yes / No
8	Are any personnel properly putting on protective garments?		Yes / No
9	Check that equipments are properly tagged with                status		Yes / No
10	Check the process rooms for presence of any unwanted material.		Yes / No
11	Check that operation in the process rooms are started after obtaining line clearance as per SOP.		Yes / No
12	Check that two products are not processed simultaneously in the same room.		Yes / No
13	Check that the identified quarantine of in process materials do not contain other materials for which is not defined.		Yes / No
14	Check that all in process containers or bags containing raw material, granules, tablets, capsules are properly labeled with Product name and Batch No.		Yes / No
15	Check that quarantine has the facilities to segregate different batch or product and check the physical segregation of material by in process quarantine.		Yes / No
16	Check the materials kept in staging room are covered, properly labeled and recorded in a staging room log.		Yes / No
17	Check that all process rooms are negative to the process area corridor. Check differential pressure record of last one month.		Yes / No
18	Check that process area and humidity is maintained as per SOP. Checks the record is maintained Properly.		Yes / No
19	Check that all instruments for measuring temperature, RH and differential pressure are tagged with approved calibration certificate sticker.		Yes / No
20	Check that there is equipment usage and cleaning log for each equipment and find that current operation is recorded in the usage log.		Yes / No
21	Review the current usage and cleaning log for each equipment and find that current operation is recorded in the usage log.		Yes / No
22	Check that product change cleaning is followed by wash water sampling for over given by QC for wash water analysis. Check last report.		Yes / No
23	Check the in process testing carried out as per SOP and recorded properly.		Yes / No
24	Inspect the IPQC laboratory. Check the calibration status and record of the IPQC laboratory equipment.		Yes / No
25	Check that change parts of equipment kept in identified place and labeled.		Yes / No
26	Check that punches are cleaned with IPA and lubricate by a smear of food grade oil.		Yes / No
27	Check that all equipments under in operations are running within its operating and BMR or other documents acceptable range as described.		Yes / No
28	Check all the balances and instrument in the process rooms for their calibration and recorded		Yes / No
29	Check that all instruments are provided with approved calibration sticker.		Yes / No
30	List of Equipment available with production department.		Yes / No
31	Are master and / or batch production records properly assembled and sufficient in the following content: Is each prepared, dated and signed in full signature by one person and independently checked, dated and signed by a second person?		Yes / No
a	Is the name, strength and description of the dosage form included?		Yes / No
b	Is the name, weight, measure of each active ingredient and total weight indicated?		Yes / No
c	Is a complete list of components provided?		Yes / No
d	Is an accurate statement of the correct measure of weight, of each competent made? Is the same weighing system used for each component?		Yes / No
e	Are statements made concerning any calculated excess of components?		Yes / No
f	Is the theoretical weight or measure at appropriate phases of production indicated?		Yes / No
g	Is there a statement of theoretically yield that includes maximum and minimum percentages beyond which an investigation is made?		Yes / No
h	Is there a description of the drug product containers, closures and packaging materials including a specimen or copy of each label and other labeling?		Yes / No
I	Are there complete manufacturing and control instructions that include any special notations or precautions that are needed?		Yes / No
j	Does the batch production records show that each significant step in the manufacture , packaging, or holding was accomplished, including:		Yes / No
k	Dates Time started and time completed?		Yes / No
l	Identify of major equipment and lines used?		Yes / No
m	Identification of each batch of competent used?		Yes / No
n	Weights and measures of components used?		Yes / No
o	In-process quality assurance results?		Yes / No
p	Inspection of the packaging and labeling area    before and after use?		Yes / No
q	Any investigations made of all discrepancies found during the final review of the production records?		Yes / No
TABLETS
1	Are all equipments surface that come into contact with the product constructed of stainless steel or special plastic or other material that is not reactive or absorptive?		Yes / No
2	Do tablet compression machine have effective dust control facilities?		Yes / No
3	Are the procedures and controls capable of detecting out of limit tablets?		Yes / No
4	Are the tablets removed from a compression cubicle or station for testing or in process control not returned to the batch? (To avoid mix-ups and contamination)		Yes / No
5	Are the rejected or discarded tablets placed in containers clearly identifying them as rejected and the quantity recorded in the batch manufacturing record?		Yes / No
6	Are there special procedures for setting up compression machines?		Yes / No
7	Is the use of punches and dies recorded in a log book as die-punch record?		Yes / No
8	Are punches and dies examined for wear and  compliance with specifications		Yes / No
9	Are punches and dies examined for wear and compliance with specifications after reaching the limit of production of tablets?		Yes / No
10	Is the air supplied to coating pans (for drying the tablets and to the spray gun for coating the tablets) filtered and of suitable quality? (Free from foreign particulate matter, water and oil droplets?		Yes / No
11	Is there a system to avoid mix-ups and errors during the inspection, sorting and polishing of the tablets?		Yes / No
CAPSULE
1	Are accurate calibrated balances used for in-process monitoring of capsule net weights? (Status label)		Yes / No
2	Are the procedures and controls capable of detecting out-of-limit capsules? (Check in –process control chart for net weight plot, hardness etc…..)		Yes / No
3	Are all bulk product containers labeled as to their content and stage of processing?		Yes / No
4	Are capsules collected into clean, labeled containers?		Yes / No
Packing
1	Check the cleanliness of area	Yes / No
2	Check that primary packaging of tablet, capsule  contains only the material or batch which is being processed.	Yes / No
3	Check that BPR is available at the site of operation and BPR is filled correctly up to the current operation.	Yes / No
4	Check the line clearance procedure and check the presence of undesirable printed packaging material stereos in the room or on the machine.	Yes / No
5	Check the BPR for the issuance of stereos.	Yes / No
6	Check the room temperature, RH and differential pressure. Check the  record	Yes / No
7	Check the personnel working in the area for their proper gowning as per SOP	Yes / No
8	Check the packing hall for segregation of packing operation of different product / batch and packing line status board is filled properly to indicate the current operation on the packing line.	Yes / No
9	Check the packaging materials are segregated and kept in locked cage.	Yes / No
10	Check the loose rolls of foils are not returned back to the warehouse and accountability is maintained properly.	Yes / No
11	Check that personnel coming in contact of product and primary packing material have worn hand gloves.	Yes / No
12	Check that balances kept in packing hall are calibrated and records are maintained.	Yes / No
13	Check that finished goods kept in packing hall with proper segregation form other product till the procedure transferred to finish good time.	Yes / No
Area Cleaning and Sanitization
14	Check that sanitizing agents are available in the plant as required by SOP.  Note: QC Reference number of one of the sanitizing agents to check the QC testing report.	Yes / No
15	Check that rotation of sanitizing agent is followed as per SOP.	Yes / No
16	Inspect the preparation of sanitizing agent dilution.	Yes / No
17	Check that cleaning aids are kept in identified place are cleaned.	Yes / No
18	Check that cleaning aids (MOPS) do not release fibers in the area.	Yes / No
Documentation
1	Check that facility is having the approved SOP bunch.	Yes / No
2	Check that all SOP in the bunch are stamped with “control” seal of QA.	Yes / No
3	Check that SOP for the operations and cleaning (batch to batch) product change overall equipment is available.	Yes / No
4	Check the SOP bunch contains all QA SOP like  training, batch release, in process , deviation , Product recall, Change control	Yes / No
5	Check the SOP bunch for the presence of SOP of instrument calibration.	Yes / No
6	Review the BMR of online process and check that up to process BMR is filled?	Yes / No