MAN-080 Example of Manufacturing Instruction for Tablet Packing Pharmaceuticals quality assurance & validation procedures GMPSOP

Department	Manufacturing		Document no	MAN-080
Prepared by:		Date:		Supersedes:
Checked by:		Date:		Date Issued:
Approved by:		Date:		Review Date:

Document Owner

Operations Manager

Affected Parties

All operation’s colleagues

Purpose

This SOP specifies the step by step instruction for the production operator to follow during tablet blistering and packing for a BPN. This SOP is written in the form of a protocol so that every time the protocol can be printed and used for different BPN.

Scope

All trained production operators of tablet packing lines have to follow this SOP while working for a BPN.

Definition

N/A

EHS Statement

No EHS impact is justified.

Procedure

1. General Instruction

1.1. Phases

Manufacturing Instruction for tablet packing consists of three main phases. Each phase number is a four digits numerical number starting with a single digit e.g. 1, 2, 3 for each separate phase. Therefore each phase can be identified with a whole number like 1000, 2000 or 3000.

1.2. Sub-phases

Each phase can be split into several sub-phases depending on the nature of the phase and ease of identification. The difference between one sub-phase to another is kept 50. Since there could be more than one sub-phases in a phase, the first instruction of a phase is the first instruction of a sub-phase. For example, the first instruction of phase 1000 starts with the sub-phase 1050.

1.3. Instruction number

Each activity needs to be done in a phase is instructed in a statement and is identified with an instruction number. The first instruction number of a sub-phase starts with digit 0010. The difference between one instruction number to another is kept 5.

2. Phases associated in a tablet packing line

2.1. Phase 1000: Dispensing.

Sub-Phase 1050

Perform line clearance in Dispensary

a. Sign all people working in the log book.

b. Check tablet containers for compliance

c. Filling of IBC bins

d. Sending IBCs and Transfer Order to production

e. Complete the phase.

2.2. Phase 2000: Blister Packing

Sub-Phase 2050

a. Signing batch started

b. Sign all people working in the log book

c. Perform line clearance in the packing line

d. Setting up Blister machine and the Cartonner

e. Start Line opening

f. Sampling of all printed components.

g. Coding of blister and carton with BPN and Expiry date

h. Sampling of formed blisters

i. Complete Line opening.

j. Perform all challenges and tests

Vision Camera system

Running in foil

Carton barcode sensor

Leaflet barcode sensor

Checkweigher

Sign Vacuum Leak Test passed

k. Complete the sub-phase

Sub-Phase 2100

a. Checking product quality

b. VLT on new foil and PVC change

c. In process check on coding block replacement

Sub-Phase 2150

VLT of formed coded blisters

Sub-Phase 2200

Temperature and Humidity test

Sub-Phase 2250

a. In process check – blister and carton

b. In process check – Shippers

c. Complete the phase

Sub-Phase 2300

Reconciliation of products and components

2.3. Phase 3000: MI sheet logbook

Sub-Phase 3050

a. Sign all people working in the MI sheet log book

b. Complete the phase

3. Protocol: Manufacturing Instruction for Tablet Packing

PROTOCOL

MI SHEET FOR TABLET PACKING – PRODUCTION

Batch Production Number:

Product Name:

Product Code:

Issued By:

(Quality Assurance)

Date:

Checked By:

(Production)

Date:

Authorized by:

(Quality Assurance)

Date

Purpose for the protocol

This Protocol contains step by step instruction for the operators to follow during tablet dispensing, tablet blister packing and final packing.

Special Instructions

To ensure compliance please remember to sign and date all entries.

The shaded areas needed a Second Independent check, Signature and Date above the highlighter.

To ensure complete documentation of this process please include all additional forms used during the manufacture of this batch and utilize the checklist on next page of this protocol.

All entries are to be clearly written directly onto the MI sheet, signed and dated.

If additional pages of forms are required staple them with this document.

If you need a Deviation Report to rise use Form-450 and follow SOP QMS-035 for understanding.

All material dispensing needs to be checked by a second independent person signed and dated and recorded in the provided log book for stock control.

Expiry date is calculated based on the shelf life. See SOP QMS-040.

Corrections and areas not needed are treated as SOP QMS-020. If no data entry is required clearly mark with N/A, sign and dated.

The density of each product can be found in the SOP QMS-090.

If you experience any difficulty with this process contact your manager or Quality Assurance staff for explanation.

Hand over the completed MI sheet with all other relevant documents associated with this BPN to Quality Assurance Department.

Production to tick and attach any of the additional forms required during the process of the BPN

Forms	Production	QA
Comments-Section
Form-035 Bulk Tablet Sampling Form
Form-190 Dispensary Label Form
Form-180 Vacuum Leak Test – New Foil and PVC Roll form
Form-200 In Process Check – Blister and Carton Form
Form-195 In Process Check – Shipper Form
Form-175 Vacuum Leak Test – Hourly Form
Form-205 People Working in the Tablet Packing Line
MI sheet for: Dispensing (phase 1000)
Blister Packing (phase 2000)
Log Book (phase 3000)

Note: QA need to check as they will receive the records with this MI sheet after finishing the batch.

Comments

BPN:	Issue Date:
Product Code:	Packing Line:
Product Name:	Page:
Phase: 1000	Operating group : Dispensing
Sub-Phase 1050/Instruction no. 0010 The instructions are for recording and dispatching bulk tablets for packing on this line.
Sub-Phase 1050/Instruction no. 0015 Before the process begins, check equipments and work station are clear of previous product, documents and/or material not required for the planned process. Check equipment is clean and suitable for use. See SOP WAR-075	Sign all clear: Follow SOP WAR-075
Sub-Phase 1050/Instruction no. 0020 If any deviation occur during the process, raise a deviation report, follow SOP QMS-035	Follow SOP QMS-035
Sub-Phase 1050/Instruction no. 0025 At the start of each shift record in the log book MI sheet the surname of all people working on this BPN on your line including technicians and trainees. Also record new people on the line as they arrive.
Sub-Phase 1050/Instruction no. 0030 Check all the tablet containers picked from the warehouse has RELEASED stickers on each of those. If any container missing the released sticker contact QC / Warehouse manager.
Sub-Phase 1050/Instruction no. 0035 Containers with bulk tablets are placed on the IBC bins and transported to the packing area. Tablets with different batch number must not be mixed in the same IBC. See SOP WAR-075.	Follow SOP WAR-075
Sub-Phase 1050/Instruction no. 0040 A maximum of three Lab. batches of bulk tablets can be mixed for the entire BPN. Do not dispatch batches with batch numbers where the date of manufacturing is more than two months apart. If this situation occur contact with your manager. Enter number of packs to be produced for this batch.	No. of packs to be produced:
Sub-Phase 1050/Instruction no. 0045 Calculate total number of tablets required for this batch. Check the MTO, Form-055 for target quantity and the issued quantity.	Number of tablets required for this batch (Form-055)
Sub-Phase 1050/Instruction no. 0050 Produce Dispensary labels for the IBCs, staple the cleaning tag and place in the plastic pouch attached with the IBC. Proceed as per SOP WAR-075	Follow SOP WAR-075 Record tablets to be dispatched: Qty, to be dispatched: Unit of measurer:

Sub-Phase 1050/Instruction no. 0055 On completion of the process enter total number of containers to be sent to packing area.			Total number of IBCs to be sent:
Sub-Phase 1050/Instruction no. 0060 Check the IBC’s are ready to be transferred in the production area.			Sign tablets ready to be sent:
Sub-Phase 1050/Instruction no. 0065 Make a list of Transfer Order number, material (tablets) code and Lab. batch numbers issued for this BPN collecting data from Material Transfer Order (Form-055).
MTO #	Mat. Code	Description	Lab. Batch #	Confirmed Quantity	Operator Initial	Sign











Sub-Phase 1050/Instruction no. 0070 Contact Laboratory to have the earliest date of manufacture for the bulk tablets. Enter as DDMMYYYY in numbers.			Earliest date of manufacture:
Sub-Phase 1050/Instruction no. 0075 Check all sub-phases are complete in the MI sheet. Check all DR’s are completed. Sign the Dispensing MI sheet off and send to production.			Sign off the MI sheet for Dispensing:

BPN:

Issue Date:

Product Code:

Packing Line

Product Name:

Page:

Phase: 2000

Operating group : Blister Packing

Sub-Phase 2050/Instruction no. 0010

Operator to sign that the batch has started

Sign batch started:

Sub-Phase 2050/Instruction no. 0015

If any deviation occur during the process, raise a deviation report, follow SOP QMS-035

Follow QMS-035

Sub-Phase 2050/Instruction no. 0020

At the start of each shift record in the log book MI sheet the surname of all people working on this BPN on your line including technicians and trainees. Also record new people on the line as they arrive.

Sub-Phase 2050/Instruction no. 0025

Perform Line clearance according to SOP MAN-055.

Fill in the form Form-160

Sign Line clearance completed:

Sub-Phase 2050/Instruction no. 0030

Set up the blistering machine, the cartoner, and perform the line opening according to SOP MAN-075

Follow SOP MAN-075

Sub-Phase 2050/Instruction no. 0035

Enter the Batch Production number and the product code as appeared on the information board.

This BPN:

This product code:

Sub-Phase 2050/Instruction no. 0040

From the warehouse:

Enter the material and batch numbers of the materials requisitioned from the ware house for this BPN. Enter the full material number. Attach samples to a sample sheet Form-120 for each batch number of each printed material.

TO #

Material code

Description

Lab. B/N

Confirmed qty.

Sign

Date

Sub-Phase 2050/Instruction no. 0045

Enter the material and batch number of printed carton.

Carton material no:

Carton batch no:

Sub-Phase 2050/Instruction no. 0050

Enter the material and batch number of PVC film.

PVC material no:

PVC batch no:

Sub-Phase 2050/Instruction no. 0055

Enter the material and batch number of printed aluminium foil.

Printed foil material no:

Printed foil batch no:

Sub-Phase 2050/Instruction no. 0060

Enter the material and batch number of leaflets

Leaflet material no:

Leaflet batch no

Sub-Phase 2050/Instruction no. 0065

Enter the material and batch number of Corrugated carton or shipper

Shipper material no:

Shipper batch no:

Sub-Phase 2050/Instruction no. 0070

Enter the material and batch number of pallet tray

Pallet tray material no:

Pallet tray batch no:

Sub-Phase 2050/Instruction no. 0075

Enter the material and batch number of slip sheet

Slip sheet material no:

Slip sheet batch no:

Sub-Phase 2050/Instruction no. 0080

Enter the material and batch number of printed shipper label.

Code the shipper label with the BPN and the expiry which is coded as MMM YYYY in characters for the month and numbers for the year. See SOP QMS-040 for how to calculate expiry date.

Follow SOP QMS-040

Shipper label material no:

Shipper label batch no:

Sub-Phase 2050/Instruction no. 0085

From the Dispensary

While packing tablets add the contents of the IBC bin to the hopper on the machine. Write the following from the IBC ID label (Form-380) on the IBC bin. Check IBC bins have cleaning tags (Form-145) on them.

For additional spaces use Dispensary Label Form (Form-190)

Form-380

Form-145

Form-190

IBC #

Material no

Batch no

No. of tablets

Time

Date

Sign

Total number of tablet delivered:

Sub-Phase 2050/Instruction no. 0090

Enter number of IBC received

Total number of IBC received:

Sub-Phase 2050/Instruction no. 0095

Calculate Expiry Date

The expiry of this product is based on three years shelf life from the date of tablet manufacture. See SOP QMS-040 for calculation of expiry date. Expiry date must be calculated from the earliest date of manufacture of bulk tablets. The expiry is coded as MMM YY.

Follow QMS-040

Earliest date of manufacture:

Sub-Phase 2050/Instruction no. 0100

Enter earliest date of manufacturing of the bulk tablets, entering this product code and this BPN in the format of DDMMYYYY/XXXXX/XXXXXX

Enter Manf. Date/Prod. Code/BPN

Sub-Phase 2050/Instruction no. 0105

Enter the three years expiry date for this product as MMMYY

Expiry date confirmed:

Sub-Phase 2050/Instruction no. 0110

Blister and Carton

Assemble the batch coder to code the blisters and the cartons with BPN and the expiry based on three years of shelf life, calculated from the earliest date of manufacture for the bulk tablets. Each blister is correctly embossed the BPN symbol as (B), BPN, the expiry symbol as EXP and Exp date. The expiry is three years calculated from the earliest date of manufacture of the bulk tablets.

Expiry to be coded with spaces MMM YY

Sub-Phase 2050/Instruction no. 0115

Sample for blisters and cartons

Write the following for a blister sample

Foil material number:

BPN Symbol (B)

BPN

Expiry

Sign

Sub-Phase 2050/Instruction no. 0120

Check on the first coded carton that the abbreviations, BPN and EXP are coded correctly. The expiry is three years.

Enter carton material number from the carton

Carton material number:

BPN Symbol (B)

BPN

Expiry

Sign

Sub-Phase 2050/Instruction no. 0125

Sign coding for blister and carton correct

Sign all coding correct:

Sub-Phase 2050/Instruction no. 0130

Attach samples of coded carton, four consecutive coded blisters and the first foil roll of the sample sheet Form-120.

Form-120

Sign printed sample taken:

Sub-Phase 2050/Instruction no. 0135

Sign that Line opening form has been completed and signed.

Sign Line Opening completed:

Sub-Phase 2050/Instruction no. 0140

The machine may now be started for the purpose of carrying out all challenges and test.

No finished packs are to be sent for final packaging until all tests are complete and pass.

Sub-Phase 2050/Instruction no. 0145

Setup and challenge the vision camera system according to SOP MAN-075 for missing or broken tablets or badly formed cups. Load program for the tablet in vision system.

Follow SOP MAN-075

Sign vision system challenge:

Sub-Phase 2050/Instruction no. 0150

Challenge the machine for running in foil

Sign running in foil rejected:

Sub-Phase 2050/Instruction no. 0155

Challenge the carton bar code reader according to SOP MAN-065

Sign carton bar code reader OK:

Sub-Phase 2050/Instruction no. 0160

Challenge the leaflet bar code reader according to SOP MAN-065

Sign leaflet bar code reader OK:

Sub-Phase 2050/Instruction no. 0165

Set and challenge the checkweigher according to SOP MAN-110. If the nominal weight is changed during the process refer to the same SOP.

Follow SOP MAN-110

Sign checkweigher set correct:

Sub-Phase 2050/Instruction no. 0170

Check set-up cartons removed off line according to SOP MAN-075.

Sign setup cartons removed:

Sub-Phase 2050/Instruction no. 0175

Check guide roll on the cartonner infeed has been adjusted to suit blister height according to SOP MAN-075

Sign guide rail adjusted:

Sub-Phase 2050/Instruction no. 0180

Check the recipe in compaker, packliner and scanware checkweigher has been reloaded according to SOP MAN-075

Sign comp/pack liner reloaded:

Sign scanware c/w reloaded:

Sub-Phase 2050/Instruction no. 0185

For the following tests failures must be recorded in the batch comment to ensure a complete record of event.

Sub-Phase 2050/Instruction no. 0190

Perform the vacuum leak test at the beginning of the batch, after maintenance of the thermo-former, after the change of foil or film and one hourly, on four consecutive blisters according to SOP MAN-095. Record the result of the Vacuum Leak Test in the vacuum Leak Test phase.

Follow SOP MAN-095

Sign start up VLT passed:

Sub-Phase 2050/Instruction no. 0195

Perform the appearance and correct blister and carton coding checks half hourly and record in the “in process checks” phase.

Sub-Phase 2050/Instruction no. 0200

Check that all entries have been made for this phase.

Check phase completed:

Sub-Phase 2100/Instruction no. 0010

Packing

The operator must constantly check the quality of the print on the foil during the entire run.

Sub-Phase 2100/Instruction no. 0015

Record the time and date that packing has started.

Time/Date packing started:

Sub-Phase 2100/Instruction no. 0020

Pack two blisters of fifteen tablets into each coded carton. Place individual carton into shipper.

Sub-Phase 2100/Instruction no. 0025

Pack cartons into shippers and stack on a pallet as per SOP MAN-035.

Follow SOP MAN-035

Sub-Phase 2100/Instruction no. 0030

New Foil and PVC Roll

For each new foil and PVC roll perform the VLT and material checks and record in the table below.

Attach a sample of each new foil roll to the printed material sample sheet Form-120. A sample of PVC is not required. For the both foil and PVC enter the material number. Record N/A for PVC product description. For additional spaces use “Vacuum Leak Test – New Foil and PVC Roll” Form (FM-180).

Form-120

Form-180

Roll#

Time

VLT

Material #

Product Description

Sign

Sub-Phase 2100/Instruction no. 0035

Sign once all new foil and PVC rolls used in the batch have been recorded. Ensure samples of each foil roll have been attached to the sample sheet.

Sign all new rolls recorded:

Sub-Phase 2100/Instruction no. 0040

Changed Coding Block

Every time the coding block is removed from the machine at any time during the production the first coded component must be rechecked and a sample attached to the sample sheet.

Record the coding block type and batch details in the table below.

Coding block #

BPN

Exp

Sign

Sub-Phase 2100/Instruction no. 0045

Sign once all packing has been completed

Sign all packing complete:

Sub-Phase 2100/Instruction no. 0050

Check that all entries have been made for this phase

Check phase completed:

Sub-Phase 2150/Instruction no. 0010

Vacuum Leak Test

Sub-Phase 2150/Instruction no. 0015

For the following test, all results including failures must be recorded in the table or batch comments to ensure a complete record of events.

Sub-Phase 2150/Instruction no. 0020

The vacuum Leak Test is performed one hourly, after any maintenance of the thermo former and after a change of foil or film.

Note: Use the “new foil and PVC roll” table (and Vacuum Leak Test-New Foil and PVC Roll Form) to record the VLT results for the change of foil and film roll.

Enter results of VLT performed on four consecutive blisters. Follow SOP MAN-095. Time format is HHMM. Enter the signature.

For additional spaces use “Vacuum Leak Test – Hourly” Form (Form-175).

Follow SOP MAN-095

Form-175

Time

Vacuum Leak Test

Sign

Sub-Phase 2150/Instruction no. 0025

Sign once all VLT have been completed

Sign all VLT testing completed:

Sub-Phase 2150/Instruction no. 0030

Check all entries have been made this phase

Check Phase completed:

Sub-Phase 2200/Instruction no. 0010

Temperature and Humidity

Record the relative humidity and ambient temperature every four hours. The humidity in the packing area must be below 50% RH. Time format is HHMM. Enter the signature.

Time (HH:MM)

Humidity

Temperature

Sign

Sub-Phase 2200/Instruction no. 0015

Sign once all humidity temperature results have been completed

Sign all hum/Tem completed:

Sub-Phase 2200/Instruction no. 0020

Check that all entries have been made for this phase.

Check phase completed:

Sub-Phase 2250/Instruction no. 0010

In Process Checks

Sub-Phase 2250/Instruction no. 0015

In process checks are to be performed every half hour at the start up and the end of the batch. Follow SOP MAN-115

Follow SOP MAN-115.

Sub-Phase 2250/Instruction no. 0020

In-process checks table Blister and Cartons. Time format is HHMM. Enter the signatures. For additional spaces use “In Process Check-Blister and Carton” Form (Form-200).

Form-200

Time

App Blstr

Blstr BPN

Blstr Exp

App carton

Carton BPN

Carton Exp

Shipp #

Sign

Sign all blister and carton inspection passed:

Sub-Phase 2250/Instruction no. 0025

In process check table for shipper

For additional spaces use “In Process Check-Shipper ” Form (Form-195).

Form-195

Time

App. Ship.

BPN Ship Label

Exp Ship Label

Shipper #

Sign

Sign all shipper inspection passed:

Sub-Phase 2250/Instruction no. 0030

Sign once all in process checks have been completed

Sign all in process checks complete:

Sub-Phase 2250/Instruction no. 0035

Retention and Test Samples

Take retention and test samples for QA evaluation and laboratory analytical testing according to SOP MAN-120. Log into “Test and Retention Samples Logbook” Form-560.

Follow SOP MAN-120

Form-560

Sub-Phase 2250/Instruction no. 0040

If any additional issue of component is made enter the data from the re-issued Material Transfer Orders into the following table. Take all printed material samples from the additional issues and attach into new sample sheet Form-120 according to SOP MAN-055

Follow SOP MAN-055

Form-120

TO #

Material code

Description

Lab. B/N

Confirmed qty.

Sign

Date

Sub-Phase 2250/Instruction no. 0045

Print out a pallet ID Form-165 and attach to each of the pallet at the front

Form-165

Sub-Phase 2250/Instruction no. 0050

Print out a Goods Booking Slip Form-210 and enter each pallet data in the form, sign and dated by two authorised operators.

Record pallet details in this sheet as prepared in the following table according to SOP WAR-040. Use Form-540 if additional spaces are required. Copy the same data into the batch reconciliation Form-125.

Follow SOP WAR-040

Form-210

Form-540

Form-125

Pallet #

Pallet qty.

Retention Sample

Stability Samples

GRS #

Sign

Date

Sub-Phase 2250/Instruction no. 0055

Post all raw material and components received during the line opening for this BPN in the Form-125.

Form-125

Sub-Phase 2250/Instruction no. 0060

Record the time and date that packing finished

Time/ Date packing finished:

Sub-Phase 2250/Instruction no. 0065

Check that all entries have been made for this phase

Check & sign Phase completed:

Sub-Phase 2300/Instruction no. 0010

Reconciliation

Sub-Phase 2300/Instruction no. 0015

On completion of the batch perform the reconciliation of the components. For the acceptable limit check SOP MAN-060. Refer to form Form-125

Follow SOP MAN-060

Form-125

Sub-Phase 2300/Instruction no. 0020

Carton Reconciliation

No. of carton received:

No. of carton packed:

No. of sample carton:

No. of rejected carton:

No. of returned carton:

Carton % Yield:

Sub-Phase 2300/Instruction no. 0025

Leaflet Reconciliation

No. of leaflet received:

No. of leaflet packed:

No. of sample leaflet:

No. of rejected leaflet:

No. of returned leaflet:

Leaflet % Yield:

Sub-Phase 2300/Instruction no. 0030

Enter number of samples taken. Enter number of packs booked out.

Follow SOP MAN-120

No. of retention plus test samples taken:

No of stability sample taken (if required):

No. of packs booked out:

Sub-Phase 2300/Instruction no. 0035

Tablet Reconciliation

Calculate the number of rejected tablets as shown in the first part. Multiply weight of one empty blister with the number of rejected blisters. Deduct the result from the total weight of rejected tablets and blisters to have the weight of rejected tablet. Divide the result by average weight of one tablet to calculate the number of rejected tablets.

Wt. of 1 empty blister:

No. of rejected blisters:

Wt. of rejected blisters:

Wt. of rejected tablet and blisters:

Wt. of rejected tablets:

Av. wt. of 1 tablet:

No. of rejected tablets:

Sub-Phase 2300/Instruction no. 0040

Final Tablet Reconciliation

No. of tablet received:

No. of tablet packed:

No. of rejected tablet:

No. of returned leaflet:

Tablet % yield:

Sub-Phase 2300/Instruction no. 0045

Place all rejected tablets and cartons in the security reject bins. Sign packing completed.

Sign packing completed:

Sub-Phase 2300/Instruction no. 0050

Check all entries have been made for this phase. Check all DR are completed. Sign the blister packing MI sheet off and send all MI sheets to QA for evaluation

Check & Sign phase completed:

Sigh MI sheet off:

Sub-Phase 2350/Instruction no. 0010

Collect all the batch documents (MI Sheets), records and forms together and logged into Form-150 according to SOP MAN-120. Send the batch document for QA evaluation and release for sale.

Follow SOP MAN-120

Form-150

BPN:			Issue Date:
Product Code:			Packing Line:
Product Name:			Page:
Phase: 3000			Operating group : Logbook
Sub-Phase 3050/Instruction no. 0010 At the start of each shift record in the log book MI sheet the surname of all people working on this BPN on your line including technicians and trainees. Also record new people on the line as they arrive. For additional spaces use “People Working In Tablet Packing Line” Form (Form-205).			Form-205
Shift #	Date	Time		Initial	Work title








Sub-Phase 3050/Instruction no. 0015 Check all entries have been made for this phase			Check phase completed:

4. Summary of Changes

Version #	Revision History
MAN-080	New

Form-035	Bulk Tablet Sampling Form
Form-210	Goods Booking Slip
Form-165	Pallet ID Form
Form-190	Dispensary Label Form
Form-055	Material Transfer Order Form
Form-070	Material Transfer Order-Return form
Form-150	Example-Logbook for Tablet Batch Documents
Form-160	FM-1076 Example- Line Clearance, Opening and Cleaning form for Tablet Packing
Form-170	Shipper Label Format
Form-180	Vacuum Leak Test – New Foil and PVC Roll form
Form-175	Vacuum Leak Test – Hourly Form
Form-200	In Process Check – Blister and Carton Form
Form-205	People Working in the Tablet Packing Line
Form-195	In Process Check – Shipper Form
Form-380	IBC Identification Label
Form-145	IBC Cleaning Tag
Form-120	Printed Material Sample Sheet
Form-125	Example- Batch Reconciliation Sheet for Tablet Packing
Form-450	Deviation Report Form
Form-540	Pallet Booking Information
Form-560	Test and Retention Sample Log Book
QMS-020	Documentation Rule for GMP Documents
QMS-035	Deviation Report System
QMS-090	Example-Evaluation of Batch Documentation for Tablet Packing
WAR-075	Example-Tablet Dispensary Procedure
WAR-080	Example-Raw Material Tablet Sampling by Dispensary
WAR-040	Finished Goods Transfer to Quarantine and Distribution Warehouse
MAN-055	Procedures for Line Clearance, Line Opening and Line Cleaning
MAN-075	Example-Tablet Packing Machine and Cartoner-construction, operation and cleaning
QMS-040	Shelf Life of Product
MAN-065	Example-Operation of Barcode Reader
MAN-110	Example-Operation of Checkweigher
MAN-095	Vacuum Leak Testing Procedure
MAN-035	Packaging Configuration for Production Line
MAN-115	Example-Tablet Packing-Start up and In-process Testing
MAN-060	Reconciliation of Component and Product
MAN-120	Example-Packed Tablet Sampling by Production Personnel for Testing

MAN-080 Example of Manufacturing Instruction for Tablet Packing

Document Owner

Affected Parties

Purpose

Scope

Definition

Related Documents

EHS Statement

Procedure